Tarrytown, NY, United States
Siemens Healthcare Diagnostics, Inc. recalls
153 recalls recorded since 2018, most recently on 17 August 2026. 86 are listed as ongoing. Status and classification are as published by the FDA.
Recalls153
Ongoing (FDA)86
Terminated or completed67
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 17 August 2026
- Reason
- The potential for falsely elevated results.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Burkina Faso, Canada, Chile, China, Columbia, Croatia, Cura¿ao, St Eus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3335-2026
- Atellica CH Revised C-Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223;
Ongoing Class II Medical devices
- Recall started
- 13 July 2026
- Reason
- Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.
- Distribution
- Worldwide - US Nationwide distribution in the state of CA and the country of Italy.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2976-2026, Z-2975-2026
- Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL
- Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
Ongoing Class II Medical devices
- Recall started
- 6 July 2026
- Reason
- Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results; Increased rate of reaction cuvette QC failures and Delayed results due to QC failures.
- Distribution
- Worldwide distribution - US Nationwide including Puerto Rico and the countries of Australia, Austria, Bahamas, Belgium, Brazil, Canada, Chile, Curacao, St. Eus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel,¿Italy,¿Latvia, Malaysia, Netherlands, New Zealand, N
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2890-2026
- Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
Ongoing Class III Medical devices
- Recall started
- 26 June 2026
- Reason
- out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated.
- Distribution
- Worldwide - US Nationwide distribution in the states CA, ID, IL, IN, MA, MS, NC, NM, NY, OH, OK, OR, PA, WA, and Northern Mariana Islands part of USA and the countries of Canada, South Africa, Brazil, Chile, Colombia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2881-2026
- Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL
Ongoing Class III Medical devices
- Recall started
- 26 June 2026
- Reason
- Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated.
- Distribution
- Worldwide - US Nationwide distribution in the states of CA and VA. The country of Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2880-2026
- Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
Ongoing Class II Medical devices
- Recall started
- 8 June 2026
- Reason
- The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Bangladesh, Bolivia, Brazil, Bulgaria, Burkina¿Faso, Canada, Chile, China, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech¿Republic, Democratic Republic Congo, Denmark, Ecuador, Egypt, El Salvador, Estonia,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2703-2026
- Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
Ongoing Class II Medical devices
- Recall started
- 7 May 2026
- Reason
- A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Brazil, Croatia, Germany, Hungary, India, Italy, Japan, Korea, Lithuania, Pakistan, Poland, Saudi Arabia, Spain, South Africa, Sri Lanka, Turkey, United Arab Emirates.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2398-2026
- Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay
Ongoing Class II Medical devices
- Recall started
- 2 April 2026
- Reason
- Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, venous, and capillary patient samples. An erroneously low pH or mTCO2 reading can lead to inappropriate treatment of nonexistent acidosis (respiratory of metabolic) or missed diagnosis of alkalosis (a true high pH: respiratory or metabolic alkalosis), potentially causing harm through unnecessary interventions with the former or failure to deliver appropriate treatment with the latter.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Italy, Spain, Austria, Portugal, Ireland, France, Romania, Canada, India, Philippines, Mexico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2005-2026
- epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;
Ongoing Class II Medical devices
- Recall started
- 18 March 2026
- Reason
- Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential imprecision in the Dimension CRE2 quality control (QC) and patient sample results using lot numbers GA6307 and BA7005 on the Dimension System. This imprecision may lead to erroneously decreased or increased creatinine patient results
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Brazil, Cambodia, Canada, Chile, China, Columbia, Costa Rica, Ecuador, Egypt, Germany, Honduras, India, Indonesia, Korea, Kuwait, Lebanon, Malaysia, Mexico, Nicaragua, Pakistan, Paraguay, Philippines,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1980-2026
- Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
Ongoing Class II Medical devices
- Recall started
- 23 February 2026
- Reason
- A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate analyzers are not impacted by the recall. The frequency and magnitude of the negative bias and imprecision increase over time and are not consistent with the assay Instructions For Use (IFU). When this issue is present, Quality Control (QC) results demonstrate a negative trend and increased imprecision. The clinical impact of a negative (A1c_E) bias may lead to a delay in diagnosis for diabetes or lead to less-than-optimal treatment for existing diabetes.
- Distribution
- Domestic: Nationwide Distribution International: Argentina, Australia, Bangladesh, Brazil, Bulgaria , Canada, Chile, China, Colombia, Croatia , Cura¿ao, St Eus, Czech Republic , Denmark , Ecuador, Egypt , Estonia , Finland , France , Georgia
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1657-2026
- Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
Ongoing Class II Medical devices
- Recall started
- 20 January 2026
- Reason
- Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL may report values between 6.2 mg/dL and 40.0 mg/dL.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Canada, Chile, Curacao,¿St¿Eus, Czech¿Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Korea, Latvia, Malaysia, Netherlands, New Zealand, Norway, Portugal, Romania,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1484-2026
- Atellica CH Urine Albumin (UAlb). Material Number: 11537225
Ongoing Class II Medical devices
- Recall started
- 6 October 2025
- Reason
- The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge.
- Distribution
- Worldwide - US Nationwide distribution in the state of CA and the countries of Argentina, Australia, Austria, Belgium, Bosnia Herzeg. , Brazil, Canary Islands, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Estonia, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Israel, Italy, Latvia
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0493-2026, Z-0492-2026, Z-0491-2026
- Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;
- 3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Specific IgE Control Antibody (L2UNS2); Siemens Material Number (SMN): 10380875; Catalog Number: L2KUN6
- IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6;
Ongoing Class II Medical devices
- Recall started
- 22 September 2025
- Reason
- The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3 pmol/L), when using specific lots identified by the firm on the IMMULITE 2000/IMMULITE 2000 XPi systems. The bias is observed in both serum and plasma samples.
- Distribution
- Worldwide - US Nationwide distribution in the states of AL, CA, DC, FL, ID, IN, LA, MD, NC, NJ, NY, PA, SC and the countries of Argentina, Australia, Bolivia, Bosnia Herzeg, Brazil, Bulgaria, Canada, Chile, Colombia, Cyprus, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Hondura
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0366-2026
- Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6;
Ongoing Class II Medical devices
- Recall started
- 11 August 2025
- Reason
- Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech¿Republic, Denmark, Egypt, Estonia, Ethiopia, Finland, France, Georgia, Germany, Greece,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2542-2025
- Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.
Ongoing Class II Medical devices
- Recall started
- 7 July 2025
- Reason
- Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some epoc test card lots. All other analytes are performing as intended. The observed average bias for sodium was -4.4 mmol/L. The maximum bias observed was -14 mmol/L, which occurred at a higher sodium concentration around 150 mmol/L. No positive bias has been observed. Quality Control (QC) fluid may or may not detect the issue depending on the bias magnitude and the frequency of QC testing.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Bahrain, Bolivia, Brazil, Canada, Canary Islands, Chile, Croatia, Denmark, Ecuador, Estonia, France, Fren. Polynesia, Germany, Greece, Guatemala, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakh
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2272-2025
- epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
Ongoing Class II Medical devices
- Recall started
- 26 June 2025
- Reason
- Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500 Systems Wash/Waste Cartridge Lot WW/08925 due to a manufacturing error causing positive and negative bias in Ionized Calcium, Potassium, pH, Chloride, pCO2, Glucose and Lactate analytes and their derivatives. Four complaints were filed related to this event that led to Siemens Healthcare Diagnostics identifying an error in the manufacturing process and initiated corrective actions. Use of the affected device may result in errors during QC which could lead to a delay in patient treatment. If bias generated from this issue is not caught during QC erroneous results may cause temporary or medically reversible adverse health consequences to patients.
- Distribution
- worldwide distribution - US Nationwide and the countries of Canada, Chile, Japan, Paraguay.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2230-2025
- RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
Ongoing Class II Medical devices
- Recall started
- 4 June 2025
- Reason
- Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
- Distribution
- Worldwide distribution - US Nationwide and the countries of AR, AU, BR, CA, CL, CN, CO, CR, HK, ID, IN, JP, KR, MX, MY, PE, PY, SA, SG, TH, TW, UY, VN, & ZA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2089-2025, Z-2088-2025, Z-2087-2025, Z-2086-2025
- ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)
- ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)
- ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)
- ADVIA¿ 120/2120/2120i SETpoint Calibrator
Ongoing Class II Medical devices
- Recall started
- 22 May 2025
- Reason
- Contamination of the diluent by sodium hypochlorite (NaOCl) which may impact calibrator, quality control (QC), and patient results for all assays except for sodium, potassium, and chloride.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Bahamas.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2027-2025
- Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;
Ongoing Class II Medical devices
- Recall started
- 15 April 2025
- Reason
- Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KY, MA, MD, ME, MI, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TX, UT, VA, VT, WI, WY and the countries of Austria, Belgium, Croatia, Curacao,¿St¿Eus, Czech¿Republi
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1821-2025, Z-1822-2025
- Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
- ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
Ongoing Class II Medical devices
- Recall started
- 31 March 2025
- Reason
- Siemens Healthcare Diagnostics Inc., is recalling their Stratus CS Acute Care cTNI TestPak, an IVD test for cardiac troponin I in heparinized plasma by removal. The reason for the recall is an increased occurrence of random non-repeatable false positive cardiac Troponin l(cTnI) results at any point during the TestPaks shelf life when using the Stratus CS cTnI Acute Care Testpak.
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, IL, KS, MI, MO, NJ, NY, OH, OK, PA, SC & WI. The countries of Austria, Canada, Chile, France, Germany, Iraq, Italy, Malaysia, North Macedonia, Saudi Arabia, Serbia, Slovenia, Spain, Sweden, Switzerland & Vietnam.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1673-2025
- Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.
Ongoing Class II Medical devices
- Recall started
- 19 March 2025
- Reason
- The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.
- Distribution
- Domestic: Nationwide Distribution; Foreign: Albania, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia, Brazil, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Croatia, Ecuador, Estonia, France, Germany, Ghana, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, I
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1684-2025, Z-1685-2025
- epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Confi
- epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736382; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Conf
Ongoing Class II Medical devices
- Recall started
- 11 March 2025
- Reason
- Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.
- Distribution
- Domestic: Nationwide Distribution. International: Australia, Austria, Bahamas, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech¿Republic, Denmark,¿Estonia, Finland, France, Germany, Greece,¿Hong Kong, Hungary, India, Ireland, Israel, Italy, Korea, Kuwait, La
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1551-2025
- Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.
Ongoing Class II Medical devices
- Recall started
- 22 November 2024
- Reason
- Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement by the device if the user of the device does not ensure verification of the correct patient name. The software malfunction has the potential to impact patient safety via misdiagnosis and/or mistreatment by a clinician if the wrong patient information is saved with the test result from the subject device.
- Distribution
- Nationwide Foreign: Albania Angola Argentina Australia Austria Bahrain Bangladesh Belarus Belgium Bolivia Bosnia and Herzegovina Brazil Cambodia Canada Chile China Colombia Croatia Czech Republic Denmark Ecuador Egypt Estonia Finland France Germany Ghana Greece Guadeloupe Hong Kong Hungary Iceland I
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0736-2025, Z-0741-2025, Z-0739-2025, Z-0734-2025, Z-0737-2025, Z-0738-2025, Z-0735-2025, Z-0740-2025
- epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples
- epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples
- epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of sample
- epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of
- epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples
- epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples
- epoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples
- epoc NXS Host; Siemens Material Number (SMN): 11413583(CN, KR) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samp
Ongoing Class II Medical devices
- Recall started
- 12 November 2024
- Reason
- Siemens Healthcare Diagnostics is recalling two lots of their Dimension Vista¿ Total Magnesium (MG) Flex Reagent Cartridges (lots 24057BB and 24064BC) due to the potential for falsely low measurements of magnesium in plasma. Because the error is intermittent, existing quality control procedures may not recognize that a patients results are incorrect, and the results may be reported out
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Slovenia, Spain.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0767-2025
- Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;
Ongoing Class II Medical devices
- Recall started
- 4 November 2024
- Reason
- Potential that the IMT Diluent volume remaining (% remaining) does not decrease as expected on the Atellica CI Analyzer, potentially leading to the IMT Diluent being empty while still displaying that volume is remaining. In this case Sodium (Na), Potassium (K) and Chloride (Cl) test results may be falsely elevated. Quality Control materials demonstrate the same behavior.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Austria, Bangladesh, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Iraq, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Malaysia, Netherlands, Oman, Pak
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0597-2025
- Atellica CI Analyzer. Catalog Numbers: 10947347.
Ongoing Class II Medical devices
- Recall started
- 21 October 2024
- Reason
- Potential for falsely depressed auto-diluted results for samples above the measuring interval of 18.00 mg/L, up to 30.00 mg/L, when using the Atellica CH ¿2-Microglobulin (B2M) reagent.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hungary, India, Iran, Israel, Italy, Ivory Coast, Japan, Jordan, Kuwait,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0599-2025
- Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plasma. Siemens Material Number (SMN): 11097635
Ongoing Class II Medical devices
- Recall started
- 21 October 2024
- Reason
- A manufacturing defect causes Atellica CH Reaction Ring Cuvette Segments with lot numbers N15 on the packaging or 15 on the underside of the cuvette segment have a potential for imprecision and erroneously depressed or elevated QC and patient results for seven (7) analytes: Ammonia, Acetaminophen, Alanine Aminotransferase (ALT), Hemoglobin A1c, Creatinine Kinase (CK), Cystatin C, and Salicylate.
- Distribution
- US Nationwide and Worldwide distribution: Foreign: Algeria Algeria Argentina Australia Austria Bahrain Bangladesh Belgium Brazil Bulgaria Burkina Faso Canada Chile China Colombia Congo, Republic C¿te dIvoire Croatia Cyprus Czech Republic Denmark Ecuador Egypt Estonia Finland France Germany Greece Ho
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0496-2025
- Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes and present them to each processing step. Siemens Material Number(SMN): 11099326 All lots starting
Ongoing Class II Medical devices
- Recall started
- 30 September 2024
- Reason
- The IMMULITE 2000 PSA assay for use on the IMMULITE 2000 and IMMULITE 2000 XPi analyzers did not meet the High-dose Hook Effect claim as stated in the Instructions for Use (IFU).
- Distribution
- Worldwide - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0464-2025
- IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)
Ongoing Class II Medical devices
- Recall started
- 24 September 2024
- Reason
- Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in one lot of epoc BGEM BUN Test Cards approximately 2 months prior to expiration. The observed maximum negative bias from internal testing is -10 mmol/L. No positive bias has been observed. Quality Control (QC) fluid may or may not detect the issue depending on the bias magnitude and the frequency of QC testing. One customer complaint has been associated with this issue. No adverse events have been reported. All affected lots have recently expired before the issuance of the recall.
- Distribution
- US Nationwide. Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0286-2025
- epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
Ongoing Class II Medical devices
- Recall started
- 21 August 2024
- Reason
- Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM analyzer.
- Distribution
- Worldwide distribution - US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3305-2024, Z-3304-2024
- Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
- ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)
Ongoing Class II Medical devices
- Recall started
- 15 August 2024
- Reason
- Atellica CH Microalbumin_2 (¿ALB_2) and the ADVIA Chemistry Microalbumin_2 (¿ALB_2) are not meeting the High-Dose Hook Effect claim/Prozone Effect claim as stated in the Instructions for Use (IFU) on the Atellica CH, Atellica CI Analyzers, ADVIA 1800 Chemistry Systems, ADVIA 2400 Chemistry Systems, and ADVIA Chemistry XPT Systems, may result in erroneously depressed microalbumin patient results.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Bosnia Herzeg, Brazil, Canada, Chile, Colombia, Croatia, Cura¿ao, St. Eus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Ho
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3169-2024, Z-3170-2024
- Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistry systems/ Atellica CH and Atellica CI Analyzers
- ADVIA Chemistry Microalbumin_2 (¿ALB_2) -For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistry systems/ Atellica CH and Atellica CI Analyzers.
Ongoing Class II Medical devices
- Recall started
- 30 July 2024
- Reason
- During manufacturing, the last three tests from the 160 test flex of lot 23206BA (wells 8 or 10) were processed on the Dimension Vista platform. There was an issue with the filling line which led to some wells to underfill in lot 23206BA. Calibrator, quality control (QC) and patient results could have been impacted.
- Distribution
- Domestic: Nationwide Distribution. International: Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Qatar, Slovenia, Spain, Switzerland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3065-2024
- Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;
Ongoing Class II Medical devices
- Recall started
- 29 July 2024
- Reason
- The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents.
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, FL, GA, IA, IL, KY, LA, MS, NJ, NY, NV, PA, TX, VA, PR and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Canada, Chile, China, Columbia, Croatia, Cura¿ao, St Eus, Czech Republic, Egypt, Estonia, Finland, France,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3063-2024, Z-3064-2024
- Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543
- ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151
Ongoing Class II Medical devices
- Recall started
- 26 July 2024
- Reason
- Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not proportional across the assay measuring interval and is less pronounced for sample results above a concentration of 110 U/mL.
- Distribution
- Worldwide - US Nationwide distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3100-2024, Z-3103-2024, Z-3102-2024, Z-3104-2024, Z-3101-2024
- Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10995490
- ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10491379 SMN: 112
- Atellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 11206239
- ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10491244
- Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN:10995489
Ongoing Class II Medical devices
- Recall started
- 17 May 2024
- Reason
- Siemens Healthineers has identified an issue with the RAPIDPoint500e system software version 5.3. This issue affects how the sample source is identified at the LIS when using the capillary mode. With this software version, samples run in the capillary mode are incorrectly labeled as arterial when displayed on the LIS, leading to the potential for results to be flagged according to an established arterial range. Capillary sample results are correctly identified as capillary on both the RAPIDPoint 500e system display and the instrument printouts. The issue only affects the new software version 5.3 and only capillary sample mode is impacted. The inability to distinguish specimen sources for blood gas may lead to incorrect diagnoses and management decisions.
- Distribution
- Worldwide - US Nationwide distribution in the states of FL, GA, LA, MI, NC and the countries of Chile, Costa Rica, France, Germany, Japan, Lebanon, Mexico, Netherlands, New Zealand, Poland, Spain, Turkey, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2214-2024
- Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e Blood Gas System (China) 11416752; RAPIDPoint 500e Blood Gas System (Japan) 11416754; RAPIDPoint
Ongoing Class II Medical devices
- Recall started
- 23 April 2024
- Reason
- The potential for falsely elevated patient sample results when using impacted lots (782, 783, 785, 786, 787, 788, 789, 790, 791, 792 and 793), of IMMULITE 2000 Anti-TG Ab.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AL, CA, DC, FL, HI, ID, IN, KS, KY MA, MI, MN, MO, NC, NJ, NY, OH, OR, PA, PR, TX, WA WI and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1886-2024, Z-1887-2024
- IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System, Test, Thyroid Autoantibody.
- IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System, Test, Thyroid Autoantibody.
Ongoing Class II Medical devices
- Recall started
- 13 March 2024
- Reason
- Potential for falsely elevated Chol_2, LDLC, and Trig_2 results on the Atellica CH and Atellica CI analyzers when the previous result in the cuvette was Iron3. Results in a positive bias ranging from 2-16% -impacts calibrator, quality control (QC), and patient results.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Curacao, St¿Eus, Czech Republic, Denmark, Estonia, Finland, France, Germany, ¿ Greece, Hungary, India, Ireland, Israel, Italy,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1549-2024
- Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and sodium heparin) using the Atellica¿ CI Analyzer and Atellica¿ CH Analyzer Siemens Material Number (SMN):
Ongoing Class II Medical devices
- Recall started
- 7 February 2024
- Reason
- The reason for the recall is that the Siemens DCA HbA1c Reagent Kit was confirmed to display a positive bias without alerting the user. The potential impact of the defect is that erroneous test results could be reported and potentially lead to incorrect patient management of glucose control. A positive bias may be observed with eleven HbA1c affected lots. Positive bias was observed when the performance of these five HbA1c lots was compared to NGSP pooled patient target-value assigned samples and the maximum bias observed was 19%.
- Distribution
- Worldwide distribution - US Nationwide and the country of Taiwan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1304-2024
- DCA Systems HbA1c Reagent Kit
Ongoing Class II Medical devices
- Recall started
- 24 January 2024
- Reason
- Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proportional across the assay measuring interval. The reference interval as claimed in the Instructions for Use (IFU) is not achieved with affected lots.
- Distribution
- Worldwide - US Nationwide distribution in the states of AL, CA, IA, IL, MI, MN, NC, NE, NV, NY, OH and TX; The countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, France, Germany, Greece, India, Italy, Japan, Latvia, Mala
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1280-2024, Z-1281-2024
- Atellica IM Erythropoietin (EPO) Assay (100 Test)
- ADVIA Centaur Erythropoietin (EPO) Assay (100 Test)
Ongoing Class II Medical devices
- Recall started
- 15 December 2023
- Reason
- Potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and PR; The countries of Argentina, Australia, Austria, Bahrain, Belgium,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1003-2024
- Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
Ongoing Class II Medical devices
- Recall started
- 26 October 2023
- Reason
- RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in serious injury due to a delayed diagnosis of hypernatremia or unnecessary intervention for hyponatremia and result in iatrogenic hypernatremia especially if the true sodium result is near the thresholds of severe alterations, as well as cause a Question Result -----? error flag for multiple electrolytes on patient samples and quality control that may cause a delay of diagnosis or treatment.
- Distribution
- Nationwide with Worldwide Distribution to: Albania Algeria Angola Argentina Armenia Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Bosnia and Herzegovina Botswana Brazil Brunei Darussalam Bulgaria Burkina Faso Cambodia Canada Chile China Colombia Congo, Republic Costa Rica
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0607-2024, Z-0608-2024, Z-0609-2024, Z-0606-2024
- RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491447
- RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491448
- RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 750-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491449
- RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10844813
Ongoing Class II Medical devices
- Recall started
- 19 October 2023
- Reason
- Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under certain conditions, a software problem is causing erroneous results to be printed. When the results are run on the epoc NXS Host and Delete Blood Tests feature is enabled, the results that are generated at the time of testing are correct; however, when this issue occurs, results that are printed, saved and/or transferred to a data manager, may include unselected analytes that are from a previous patient or QC test. The worst possible outcome may result in a failure to diagnose hyperkalemia, due to an erroneous depressed potassium level or inappropriate treatment to hyperglycemia due to erroneous glucose reading.
- Distribution
- US Nationwide. Global Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0601-2024
- epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW), 11413498 (JP), 11413583 (CN, KR), 11413879 (IN) with software versions from 4.9.4
Ongoing Class II Medical devices
- Recall started
- 26 September 2023
- Reason
- There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause falsely elevated sodium results reported on the RAPIDPoint 500 and RAPIDPoint 500e Blood Gas Systems. The erroneous sodium levels with positive bias may lead to unrecognized hyponatremia and/or the inappropriate treatment of hypernatremia may lead to iatrogenic hyponatremia, resulted in a delay in patient diagnosis and optimal patient management.
- Distribution
- Domestic: Nationwide Distribution. Foreign: Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Burkina Faso, Cambodia, Canada, Chile, China, Colombia, Con
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0423-2024, Z-0422-2024
- RAPIDPOINT 500 Blood Gas System
- RAPIDPOINT 500e Blood Gas System
Ongoing Class II Medical devices
- Recall started
- 8 August 2023
- Reason
- There is a potential for a positive bias on Quality Control (QC) and patient sample results when using some IRON_2 reagent wedge pairs. When the issue occurs, the observed bias will vary wedge to wedge.
- Distribution
- US Nationwide. Global Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2666-2023
- ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests)
Ongoing Class II Medical devices
- Recall started
- 25 July 2023
- Reason
- There is a potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Creatinine_2 (ECRE_2). Falsely depressed ECRE_2 results may be observed when the assay is processed after the UCFP test on ADVIA Chemistry systems.
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, CO, CT, FL, GA, IA, MD, MI, NJ, NM, NY, OH, PA, SD, TX, UT, and VA. Global distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2451-2023
- ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use in the quantitative determination of total protein in human urine and cerebrospinal fluid
Ongoing Class II Medical devices
- Recall started
- 10 July 2023
- Reason
- Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica¿CH Total Bilirubin_2 (TBil_2), Atellica¿ CH LDL Cholesterol (LDLC), Atellica¿ CH Gamma-Glutamyl Transferase (GGT) and Atellica¿ CH HDL Cholesterol (HDLC)
- Distribution
- US Nationwide - Worldwide Distribution Foreign: Taiwan Uruguay Vietnam
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2473-2023, Z-2474-2023, Z-2471-2023, Z-2472-2023
- Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma (lithium heparin Test Code: GGT Siemens Material Number (SMN):
- Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium Heparin) Test Code: HDLC Siemens Material Number (
- Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates Test Code: TBil_2 Siemens Material Number
- Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium heparin Test Code: LDLC Siemens Material Number (SMN)
Ongoing Class II Medical devices
- Recall started
- 1 June 2023
- Reason
- There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.
- Distribution
- US distribution to AL, AR, AZ, CA, CO, DC, DE, FL, IA, ID, IL, KS, KY, LA, MI, MN, MO, NC, ND, NH, NY, OH, OK, SC, SD, and TX OUS distribution to Canada, China, Colombia, Finland, India, Mexico, Norway, Sweden, United Arab Emirates, and Vietnam
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2477-2023, Z-2478-2023, Z-2476-2023
- epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
- epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
- epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
Ongoing Class II Medical devices
- Recall started
- 16 May 2023
- Reason
- A firmware error may lead to an incorrect association of test result(s) to a sample ID and therefore to an incorrect patient result. The mis-association of test results, or a delay in testing, may occur when all the conditions listed below occur within a few milliseconds timeframe of each other: - The SRM module is releasing a sample tube (Tube A) just placed into the carrier - Another sample tube (Tube B) is erroneously not diverted into the SRM module buffer - There is divert gate malfunction and a narrow timing window Only in this specific scenario, Tube A may be released by the module as Tube B due to a miscommunication between the module firmware and the Automation software without a unique error message being generated. The Automation System loses the traceability of Tube A. It manages both Tube A (incorrectly identified as Tube B) and the real Tube B according to the pending test orders (not yet performed) on Tube B.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CA, CO, FL, IL, KY, LA, MA, MD, MI, MS, MT, NC, NH, NY, OH, PA, SC, TN, TX, VA, WA, & WV. The countries of Australia, Brazil, Canada, China, France, Germany, Greece, Italy, Portugal, Saudi Arabia, Spain, Sweden, & United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2091-2023
- Aptio Automation Storage and Retrieval Module (SRM)
Ongoing Class II Medical devices
- Recall started
- 5 April 2023
- Reason
- Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia Calibrators for the Atellica CH Salicylate (Sal) Assay due to a positive bias
- Distribution
- US Nationwide and Worldwide Distribution Foreign: Argentina Australia Austria¿¿¿¿¿¿¿¿ Bahrain¿¿¿¿¿¿¿¿ Bangladesh Belgium¿¿¿¿¿¿¿¿ Bosnia¿Herzeg.¿ Brazil Canada Chile China Colombia Czech¿Republic¿ Egypt¿¿¿¿¿¿¿¿¿¿ Estonia¿¿¿¿¿¿¿¿ Finland¿¿¿¿¿¿¿¿ France¿¿¿¿¿¿¿¿¿ Georgia¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Greece¿¿
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1632-2023, Z-1631-2023
- Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica¿ CH Toxicology Calibrator (TOX CAL) is for in vitro diagnostic use in calibrating the Acet, ETOH and Sal assays using the Atellica¿ CH Analyzer Siemens Material Nu
- ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of ethanol (ETOH_2), ammonia (AMM), acetaminophen (ACET), and salicylate (SAL) assays on the ADVIA¿ Chemistry systems Siemens Material Num
Ongoing Class II Medical devices
- Recall started
- 16 March 2023
- Reason
- There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.
- Distribution
- Worldwide distribution - US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1504-2023, Z-1505-2023
- Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 11206248). In vitro diagnostic use in the quantitative determination of cortisol in human serum, plasma
- ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T (Material Number 10994926), and ADVIA Centaur Cortisol REF 250T (Material Number 10994927). In vitro diagnostic use in the quantitative d
Ongoing Class II Medical devices
- Recall started
- 30 January 2023
- Reason
- Siemens Healthineers has received customer complaints and confirmed imprecision for Quality Control (QC) and patient samples with Dimension Tacrolimus (TAC) lots GA2286, GA3047 and GA3171. The health consequences of erroneous patient results are major, since in a worst case scenario, a patient s tacrolimus dosing could be altered, resulting in potential organ failure and rejection (due to too low or no tacrolimus being administered) or toxicity (due to too much tacrolimus being administered). Siemens internal investigation of the Dimension TAC assay showed the worst case imprecision with patient samples at the low end of the Analytical Measurement Range (AMR). A patient sample at 2.0 ng/mL (2.6 nmol/L) recovered as 0.0 ng/mL (0.0 nmol/L) (100% negative bias), another patient sample at 2.1 ng/mL (2.7 nmol/L) recovered at 4.3 ng/mL (5.6 nmol/L) (103% positive bias).
- Distribution
- Worldwide and Nationwide Distribution Foreign: Aregentina Brazil Chile Colombia Country India Japan New Zealand Nicaragua Saudi¿Arabia¿¿¿ South Africa South Korea Spain¿¿¿¿¿¿¿¿¿¿ Sri Lanka Taiwan
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1258-2023
- Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative measurement of tacrolimus in human whole blood on the Dimension¿ clinical chemistry system SMN: 10700795 (DF207)
Ongoing Class II Medical devices
- Recall started
- 27 January 2023
- Reason
- Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results
- Distribution
- Nationwide Foreign: Country Albania Algeria Argentina Australia Austria Bahrain Bangladesh Belgium Brazil Bulgaria Burkina Faso Canada Chile China Colombia Croatia Cura¿ao Czech Republic Denmark Ecuador Egypt Finland France Germany Greece Guadeloupe Hong Kong Hungary India Ireland Israel Italy Japan
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1270-2023, Z-1268-2023, Z-1269-2023, Z-1271-2023
- Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plasma (lithium heparin, potassium EDTA) using the Atellica CH Analyzer SMN: 11097591
- Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin) using the Atellica CH Analyzer. SMN: 11097632
- Atellica CH Total Protein II- In vitro diagnostic use in the quantitative determination of total protein in human serum and plasma (lithium heparin) using the Atellica CH Analyzer. SMN: 11097604
- Atellica CH Triglycerides_2: in vitro diagnostic use in the quantitative determination of triglycerides in human serum and plasma (lithium heparin, sodium heparin, potassium EDTA) using the Atellica CH Analyzer. SMN: 115
Ongoing Class II Medical devices
- Recall started
- 9 January 2023
- Reason
- Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
- Distribution
- Nationwide Foreign: Albania¿¿¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿ Bahrain¿¿¿¿¿¿¿¿ Belgium¿¿¿¿¿¿¿¿ Bosnia¿Herzeg.¿ Bulgaria¿¿¿¿¿¿¿ Croatia¿¿¿¿¿¿¿¿ Cura¿ao,¿St¿Eus Cyprus¿¿¿¿¿¿¿¿¿ Czech¿Republic¿ Denmark¿¿¿¿¿¿¿¿ Estonia¿¿¿¿¿¿¿¿ Finland¿¿¿¿¿¿¿¿ France¿¿¿¿¿¿¿¿¿ Georgia¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Greece¿¿¿¿¿¿¿¿¿ Hungary¿
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1149-2023, Z-1151-2023, Z-1152-2023, Z-1150-2023, Z-1154-2023, Z-1153-2023
- Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995572
- Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 11206252
- ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10310308
- Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995573
- ADVIA Centaur Folate 500 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10331250 Siemens Material N
- ADVIA Centaur Folate 500 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10325366
Ongoing Class II Medical devices
- Recall started
- 22 December 2022
- Reason
- Anti-HBe2 (aHBe2) interference with the Hepatitis B e Antigen (HBeAg) Assay, leads to elevated or reactive Hepatitis B e Antigen (HBeAg) results on samples that are non-reactive when HBeAg testing follows aHBe2 testing, regardless of whether both tests are performed on the same sample
- Distribution
- US Nationwide distribution in the states of GA, UT.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1143-2023
- ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic immunoassay for the qualitative detection of antibodies to the e antigen of the hepatitis B virus (HBV) in human pediatric (2-21 years old
Ongoing Class II Medical devices
- Recall started
- 12 December 2022
- Reason
- pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure
- Distribution
- Nationwide Foreign: Algeria Argentina Australia Austria Bahrain Belarus Belgium Bolivia Brazil Cambodia Canada Chile China Colombia Croatia Czech Republic Denmark Ecuador Egypt Estonia Finland France Fren.Polynesia Georgia Germany Greece Guadeloupe Hong Kong Hungary Iceland India Indonesia Iran Irel
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1214-2023, Z-1215-2023
- epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, China 10736389 epoc Host 2, Japan 10736390 epoc Host 2, Refurbished 10736393 epoc Host 2, Canada
- epoc Host 2 as follows: Product SMN epoc NXS Host, US 11413475 epoc NXS Host, EU 11413497 epoc NXS Host, Japan 11413498 epoc NXS Host, Canada 11413506 epoc NXS Host, ROW 11413518 epoc
Ongoing Class II Medical devices
- Recall started
- 7 December 2022
- Reason
- Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit lots; control level one may result outside of published ranges; when control results are in range, users may observe increased imprecision with low level patient samples
- Distribution
- Nationwide Foreign: Argentina¿¿¿¿¿¿ Australia¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿ Bahrain¿¿¿¿¿¿¿¿ Bangladesh¿¿¿¿¿ Belgium¿¿¿¿¿¿¿¿ Bolivia¿¿¿¿¿¿¿¿ Bosnia¿Herzeg.¿ Brazil¿¿¿¿¿¿¿¿¿ Bulgaria¿¿¿¿¿¿¿ Canada¿¿¿¿¿¿¿¿¿ Chile¿¿¿¿¿¿¿¿¿¿ Colombia¿¿¿¿¿¿¿ Costa¿Rica¿¿¿¿¿ Croatia¿¿¿¿¿¿¿¿ Cyprus¿¿¿¿¿¿¿¿¿ Czech¿Republic¿ Dominica
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0949-2023, Z-0950-2023
- IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers (IMMULITE 2000/ IMMULITE 2000 XPi) for the quantitative measurement of thyroglobulin in serum or heparinized plasma
- IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of thyroglobulin in serum or heparinized plasma, as an aid in monitoring patients
Ongoing Class II Medical devices
- Recall started
- 4 November 2022
- Reason
- Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result
- Distribution
- Worldwide distribution. US Nationwide, Argentina¿¿¿¿¿¿ Australia¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿ Azerbaijan¿¿¿¿¿ Belgium¿¿¿¿¿¿¿¿ Brazil¿¿¿¿¿¿¿¿¿ Chile¿¿¿¿¿¿¿¿¿¿ Colombia¿¿¿¿¿¿¿ Costa¿Rica¿¿¿¿¿ Croatia¿¿¿¿¿¿¿¿ Czech¿Republic¿ Denmark¿¿¿¿¿¿¿¿ Ecuador¿¿¿¿¿¿¿¿ Egypt¿¿¿¿¿¿¿¿¿¿ Estonia¿¿¿¿¿¿¿¿ France¿¿¿¿¿¿¿¿¿ Germ
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0718-2023, Z-0716-2023, Z-0717-2023
- IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SMN): 10711939 For the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical dia
- IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US. Siemens Material Number (SMN): 10708840 For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measureme
- IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, except Japan Siemens Material Number (SMN): 10380875 For the quantitative measurement of allergen-specific IgE in human serum, as an aid in the
Ongoing Class II Medical devices
- Recall started
- 25 October 2022
- Reason
- Confirmed an average positive bias of 40% for testosterone concentrations of approximately 660 ng/dL (22.9 nmol/L) and above with the IMMULITE/IMMULITE 1000 Total Testosterone Assay when compared to the IMMULITE 2000/IMMULITE 2000 XPi Total Testosterone Assay. Two (2) lots of Total Testosterone assays for the IMMULITE/IMMULITE 1000, kit lots #515 and #516 were actively distributed to customers when the issue was discovered by Siemens, and they are subject to the correction or removal in this recall (867 total quantity of reagents distributed for each lot). The violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. In both males and female, testosterone results are not used in isolation but are interpreted in conjunction with clinical history and symptomology as well as with other laboratory testing (e.g. gonadotropins and other sex steroids). A delay in the diagnosis may be experienced and medical intervention, such as repeat testing may be required.
- Distribution
- Worldwide Distribution: US (nationwide) to states of: AL, CA, FL, GA, IN, KY, NC, NE, OR, SD, TX, UT; and OUS (Foreign) to countries of: Canada, Mexico, Austria, Argentina, Austria, Bangladesh, Colombia, Brazil, Bulgaria, Costa¿Rica, Cyprus, Estonia, Germany, Greece, India, U.A.E.,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0355-2023
- IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers for the quantitative measurement of total testosterone in serum and heparinized plasma.
Ongoing Class II Medical devices
- Recall started
- 19 September 2022
- Reason
- Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the worst case, there is a potential for erroneously elevated lithium patient results, which may lead to inappropriate dosage adjustment, potentially affecting treatment efficacy.
- Distribution
- Worldwide distribution - US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0105-2023, Z-0104-2023
- Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
- Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay
Ongoing Class II Medical devices
- Recall started
- 30 August 2022
- Reason
- N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF).
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0093-2023, Z-0094-2023
- N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297
- N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299
Ongoing Class II Medical devices
- Recall started
- 24 August 2022
- Reason
- Dimension Vista¿ High Density Lipoprotein Cholesterol (HDLC) Potential for Erroneous Result. If an HDLC QC or patient result is obtained without an Abnormal Reaction [E145]: flag, a falsely depressed or elevated result ranging from -90% to 133% may be observed.
- Distribution
- Nationwide Foreign: Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0089-2023
- Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN): 10464340 Catalog Number: K3048A
Ongoing Class II Medical devices
- Recall started
- 17 August 2022
- Reason
- Dimension Magnesium (MG) Flex reagent cartridge lots may exhibit imprecision for Quality Control (QC) and produce Abnormal Reaction flags. The issue is not always detected by QC and erroneous results may be produced in the absence of an Abnormal Reaction flag. Based on customer data, imprecision leading to erroneous, unflagged patient results with a bias of -15 to -59% may occur
- Distribution
- Nationwided Foreign: Afghanistan¿¿¿¿ Albania¿¿¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿ Bahrain¿¿¿¿¿¿¿¿ Bosnia¿Herzeg.¿ Bulgaria¿¿¿¿¿¿¿ Canada Croatia¿¿¿¿¿¿¿¿ Czech¿Republic¿ Egypt¿¿¿¿¿¿¿¿¿¿ France¿¿¿¿¿¿¿¿¿ Georgia¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Greece¿¿¿¿¿¿¿¿¿ Hungary¿¿¿¿¿¿¿¿ Israel¿¿¿¿¿¿¿¿¿ Italy¿¿¿¿¿¿¿¿¿¿ Jordan¿¿¿
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1816-2022
- Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog Number):10444963/DF57
Ongoing Class II Medical devices
- Recall started
- 11 August 2022
- Reason
- An average negative bias of -23% with IMMULITE 2000/IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) when compared to other in-date kit lots, there is a potential for erroneously depressed patient results. This may lead to a delayed follow up of patients with clinical autoimmune thyroid
- Distribution
- Worldwide Distribution: US (nationwide) to states of: FL IN MA MI NH NJ NY OH TX UT and OUS (Foreign) countries of: Aus
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1820-2022
- IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) Siemens Material Number (SMN): 10876421 US; 10713448 (OUS)
Ongoing Class II Medical devices
- Recall started
- 18 July 2022
- Reason
- Negative bias with patient samples. The mean patient sample bias range from -26% to -33%,potential risk of delay in appropriate treatment and management decisions.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Austria, France, ¿¿ Germany, Italy, Switzerland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1648-2022
- Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3. Siemens Material Number (SMN)/Ref Catalog Number : 10464344/K6456
Ongoing Class II Medical devices
- Recall started
- 28 June 2022
- Reason
- Falsely Elevated Atellica CH Microalbumin_2 (¿ALB_2) Results due to Reagent Carryover from the Iron_2 Assay. This defect occurs only when a microalbumin test is run immediately after an iron test.
- Distribution
- Worldwide distribution - US Nationwide and the countries of AR, AU, AT, BS, BH, BD, BE, BR, BG, BF, CA, CL, CO, HR, CW, CZ, DK, EC, EG, EE, FI, FR, DE, GR, GP, HK, HU, IN, IR, IQ, IE, IL, IT, JP, JO, KE, KW, LV, LY, LT, MY, MX, MA, NL, NZ, NO, OM, CN, PK, PY, PE, PH, PL, PT, QA, KR, RO, RU, SA, R
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1498-2022
- Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and (lithium heparin) plasma samples.
Ongoing Class II Medical devices
- Recall started
- 1 June 2022
- Reason
- Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support.
- Distribution
- AL CA CO FL IA ID KS NM OK TX
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1372-2022
- epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood Product Siemens SMN#/Model #: 1073
Terminated Class II Medical devices
- Recall started
- 18 May 2022
- Terminated
- 13 February 2025
- Reason
- Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/mL [0.07 ¿g/L], may lead to inappropriate intervention for myocardial infarction
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, AR, CA, IL MN, MS, NC, ND, NH, OK, SD, TN, TX, WA and the countries of Argentina, Brazil, Canada, France, Germany, India, Mexico, Poland, Portugal, Slovakia, Spain.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1340-2022, Z-1341-2022
- Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Material Number (SMN)/R
- Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Material Number (SMN)/RE
Ongoing Class II Medical devices
- Recall started
- 13 April 2022
- Reason
- Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results
- Distribution
- Worldwide distribution - US Nationwide and the countries of Albania, Argentina, Austria, Bahamas, Bangladesh, Belgium, Brazil, Chile, China, Columbia, Croatia, Czech¿Republic, Denmark, Ecuador, Egypt, France, Germany, Greece, India, Israel, Italy, Japan, Korea, Latvia, Malaysia, Mexico, Netherlands,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1252-2022, Z-1253-2022
- Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001
- Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens Siemens Material Number (SMN): 11066000
Ongoing Class II Medical devices
- Recall started
- 3 March 2022
- Reason
- Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
- Distribution
- Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Brazil, Bulgaria, Burkina, Faso Country AG, Cyprus, Denmark, Egypt, Estonia, Finland, France, French Polynesia, Georgia, Greece, Guadeloupe, India, Ireland, Israel, Italy, Kazakhstan, Latvia, Lithuania, Macedonia, Malta, M
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1024-2022, Z-1025-2022, Z-1022-2022, Z-1021-2022, Z-1023-2022, Z-1020-2022
- ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10491445 All lots
- ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative detection of estradiol SMN: 10697757 All lots
- Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 11206250 All lots
- Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995562 All lots
- ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10490889 All lots
- Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995561 All lots
Ongoing Class II Medical devices
- Recall started
- 22 February 2022
- Reason
- Potential for falsely elevated hCG results due to sample carryover in serum and urine patient samples, as well as quality control samples and adjustors.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, ID, IN, MN, NC, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TX, VA, WI, WY and OUS: 81 countries.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1015-2022
- IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog number L2KCG6]
Ongoing Class II Medical devices
- Recall started
- 9 February 2022
- Reason
- Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.
- Distribution
- Global Distribution. US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0930-2022, Z-0931-2022, Z-0929-2022, Z-0928-2022
- Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637
- Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637
- Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536
- Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644
Ongoing Class II Medical devices
- Recall started
- 28 January 2022
- Reason
- Dimension Vista Magnesium Flex reagent cartridge lots exhibiting imprecision and intermittent Abnormal Assay flags. When this issue occurs, there is a potential for QC failures or erroneous patient results which may lead to repeat and follow-up testing.
- Distribution
- Worldwide distribution: US (nationwide) 47 States including: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY) and OUS countries of: Australia, Canada and Nether
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0830-2022
- Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in the Dimension Vista System. The Dimension Vista Magnesium Flex Reagent (MG) method is an In vitro diagnostic
Terminated Class II Medical devices
- Recall started
- 1 December 2021
- Terminated
- 7 July 2023
- Reason
- ¿2 Microglobulin (B2M) Reagent Lot 211446 Bias with Quality Control and Patient Sample Results. Positive bias on patient samples of up to +20.9% at a B2M concentration of approximately 1.5 mg/L and a negative bias on patient samples of up to -10.5% at a B2M concentration of approximately 15 mg/L
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CA, CO, MA, MD, MS, NC, NE, NH, OH, VA, WI and the countries of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Czech Republic, Denmark, Ecuador, France, Germany, Greece, India, Iran, Israel, Italy, Japan, Mexico, Morocc
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0440-2022
- Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plasma Siemens Material Number (SMN): 11097635
Ongoing Class II Medical devices
- Recall started
- 18 November 2021
- Reason
- (1)Software (SW) versions V1.25.1 and lower may result in TDef (Test Definition) Parameters for Open Channel Assays reverting to Default Value would shift test results by the magnitude of the implemented Assay Correlation factor; (2) On Board Stability (OBS) Not Updating with Manual Change for Open Channel Assays may continue to use the reagent past its expiration date leading to potential erroneous patient sample results
- Distribution
- Nationwide Foreign: AU DE AE TR BG CL IN CZ BR ES KE CN PL SA BE IQ IT CW SE AR CO GR SK EE KR JP UY DK FR GB VN CA BD MX TH DZ PT RU ZA PK HU NL VA NO AT IR LV EG PH SG MY IL FI HR MA KW CH TW BH AL BF UG NZ OM HK QA PE EC IE GP LY LT
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0449-2022
- Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11067000
Terminated Class II Medical devices
- Recall started
- 15 October 2021
- Terminated
- 13 May 2024
- Reason
- Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of DE, ES, FR, IT, CA, NL, JP, PT, AU, CZ, AT, DK, SI, BE, SK, QA, SA, KR, CH.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0331-2022, Z-0330-2022
- Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body f
- Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body f
Ongoing Class II Medical devices
- Recall started
- 6 October 2021
- Reason
- The Aptio Automation Firmware for the ADVIA Centaur XP/XPT Interface Module may lead, in some cases, to an incorrect association of test results to sample ID. Incorrect association of test results could impact clinical interpretations and clinical decisions.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0193-2022
- Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1 and lower. SMN 10703038
Ongoing Class II Medical devices
- Recall started
- 28 September 2021
- Reason
- Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result, customers at these altitudes may observe an increased number of Reagent Volume Check Errors.
- Distribution
- Domestic distribution to AZ CA CO GA ID KS MO MT NC NE NM NV OH OK OR PA TN TX UT VA WA WI WY. Foreign distribution worldwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0125-2022, Z-0124-2022
- Atellica IM 1600 Analyzer, SMN 11066000
- Atellica IM 1300 Analyzer, SMN 11066001
Terminated Class II Medical devices
- Recall started
- 22 September 2021
- Terminated
- 2 August 2022
- Reason
- Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.
- Distribution
- US Nationwide distribution in the states of AK, CA, CO, DC, GA, IL, ME, NC, NV, NY, OR, PA, PR, VA and VI.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0196-2022, Z-0195-2022
- ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866
- Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
Ongoing Class II Medical devices
- Recall started
- 20 September 2021
- Reason
- The firm has confirmed the potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c results may affect consideration of intervention.
- Distribution
- Worldwide distribution - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0181-2022, Z-0180-2022
- Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151
- Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543
Ongoing Class II Medical devices
- Recall started
- 6 July 2021
- Reason
- Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot numbers
- Distribution
- Worldwide distribution. US Nationwide, Australia, Bahamas, India, Mexico, Saudi Arabia, and Viet Nam
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2425-2021, Z-2426-2021, Z-2424-2021
- Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995477
- Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer.- SMN
- Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995478
Terminated Class II Medical devices
- Recall started
- 18 May 2021
- Terminated
- 30 August 2024
- Reason
- ADVIA Chemistry System and Software Versions (V1.4 SMN 11314625 and V1.4 China SMN 11316885) may not be aligned with customer expectations for the current default mixer failure detection setting of 2; an erroneously elevated or depressed patient result to be reported without alert on the test result
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CA, CO, CT, FL, MA, MD, MI, MN, NY, OH, PA, TX and the countries of Australia, Bahrain, Brazil, Canada, Chile, Croatia, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Italy, Malaysi
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2014-2021
- The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch
Ongoing Class II Medical devices
- Recall started
- 13 May 2021
- Reason
- Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking over time. The leaking is a risk in valves subject to high pressure or high wear and may impact the result accuracy of any assay.
- Distribution
- Nationwide Foreign: Country Name Algeria Argentina Australia Austria Bahrain Bangladesh Belgium Brazil Bulgaria Burkina Faso Canada Chile Colombia Croatia Cura¿ao Cyprus Czech Republic Denmark Ecuador Egypt Estonia Finland France Germany Greece Hungary India Indonesia
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2027-2021, Z-2028-2021, Z-2026-2021
- Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066001
- Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066000
- Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11067000
Ongoing Class II Medical devices
- Recall started
- 4 May 2021
- Reason
- Photometer Lamp May Reach Saturation Without Flagging Results, may generate erroneously elevated or depressed patient results
- Distribution
- Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Burkina Faso, Canada, Chile, Colombia, Croatia Cura¿ao, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Ho
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1870-2021
- Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000
Ongoing Class II Medical devices
- Recall started
- 21 April 2021
- Reason
- Potential for the ADVIA Centaur Syphilis assay to carryover into other commercial assays. This carryover effect only occurs when the impacted assays are used immediately following testing with the Syphilis assay on the ADVIA Centaur XP/XPT or ADVIA Centaur CP systems
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Austria, Belgium, Burkina Faso, Croatia, Czech Republic, Egypt, Finland, France, Fren.Polynesia, Georgia, Germany, Germany, Greece, Guadeloupe, Italy, Kazakhstan, Latvia, Netherlands, Norway, Poland, Portugal, Qatar, Russian Fe
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1674-2021
- Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagnostic use in the qualitative determination of antibodies to Treponema pallidum in human serum or plasma using the ADVIA Centaur XP/XPT System an
Ongoing Class II Medical devices
- Recall started
- 5 March 2021
- Reason
- Potential Sample Identification (SID) Mismatch with14-Character Barcodes
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bosnia Herzeg., Botswana, Brazil, Bulgaria, Burkina, Faso, Cambodia, Canada, Chile, Colombia, Croatia, Cura¿
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1405-2021, Z-1394-2021, Z-1390-2021, Z-1396-2021, Z-1402-2021, Z-1386-2021, Z-1398-2021, Z-1395-2021, Z-1393-2021, Z-1403-2021, Z-1399-2021, Z-1401-2021 and 8 more
- ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
- ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - US, automated hematology analyzer Software Versions 6.10 and 6.11
- ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - US, automated hematology analyzer Software Versions 6.10 and 6.11
- ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
- ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
- ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated hematology analyzer Software Versions 6.10 and 6.11
- ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
- ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - US, automated hematology analyzer Software Versions 6.10 and 6.11
- and 12 more product lines
Terminated Class II Medical devices
- Recall started
- 2 March 2021
- Terminated
- 10 June 2022
- Reason
- Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected by a potential Emicizumab carryover on patient samples.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, WV and the countries of Argentina, Austria, Belarus, Belgium, Bosnia Herzegovina, Brazil, Canada,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1435-2021
- BCS XP System: Multipurpose system for in vitro coagulation studies. Product code: 10459330, 10461894, 10470625 - Product Usage: The Behring Coagulation System is an instrument intended to perform quantitative assays of
Terminated Class II Medical devices
- Recall started
- 8 February 2021
- Terminated
- 7 February 2025
- Reason
- Potential false positive HSV results. Siemens Healthcare Diagnostics, Inc. initiated a correction for ADVIA Centaur4P Herpes-2 lgG (HSV2) Onboard Stability and Calibration Frequency (Interval) Failures on the ADVIA Centaur XP System and ADVIA Centaur XPT System.
- Distribution
- Domestic: AL, CA, FL, IL, MD, NJ, NY, TN, TX. Foreign: Nepal, Chile, Georgia, Spain.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1274-2021
- Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2
Ongoing Class II Medical devices
- Recall started
- 3 February 2021
- Reason
- Siemens Healthcare Diagnostics Inc. has confirmed the potential for erroneous results due to discolored reagent observed in some wells 5 and 6 of Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridges lot 20062BA.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, WV, WY, and the countries of Austria, Belgium
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1188-2021
- Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases, and in the assessment of risk fo
Terminated Class II Medical devices
- Recall started
- 2 December 2020
- Terminated
- 6 June 2024
- Reason
- Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cura¿ao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0862-2021, Z-0861-2021, Z-0863-2021
- Atellica IM 1300 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066001 - Product Usage: intended for the qualitative and quantitative analysis of various body fluid
- Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11067000 - Product Usage: intended for the qualitative and quantitative analysis of various body fluids
- Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066000 - Product Usage: intended for the qualitative and quantitative analysis of various body fluid
Ongoing Class II Medical devices
- Recall started
- 23 November 2020
- Reason
- Gamma-Glutamyl Transferase (GGT) Reagent Low End Repeatability-Imprecision. Reagent may demonstrate a coefficient of variation (%CV) outside of the performance data for repeatability (within-run) listed in the Instructions For Use (IFU) on some analyzers.
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Australia, Austria, Bahamas, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, India, Iran, Ireland, Is
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0722-2021, Z-0721-2021
- Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma. Siemens Material Number (SMN): 110
- ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma. Siemens Material Number (SMN): ADVIA
Terminated Class II Medical devices
- Recall started
- 26 October 2020
- Terminated
- 19 April 2024
- Reason
- Test Definition scanning may reset custom settings to defaults causing falsely low or high results. When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef version is a newer version than the version that is currently on the system, some of the customer defined settings for that assay may reset to default values
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cura¿ao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, German
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0473-2021, Z-0474-2021
- Atellica IM 1300 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001
- Atellica IM 1600 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066000
Ongoing Class II Medical devices
- Recall started
- 22 September 2020
- Reason
- Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to a potential adjustment of hyperglycemic therapy. Positively biased fructosamine results may prompt changes in glucose management that may affect glycemia. In extreme situations, more aggressive management of glycemia may occur and contribute to hypoglycemia.
- Distribution
- CA, DE, MD, NC, NJ, NY, PA Foreign: Argentina¿¿¿¿¿¿ Australia¿¿¿¿¿¿ Brazil¿¿¿¿ Canada¿¿¿¿¿ Czech¿Republic¿ Denmark¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Italy¿¿¿¿¿¿¿¿¿¿ Netherlands¿¿¿¿ P.R.¿China¿¿¿¿¿ Paraguay¿¿¿¿¿¿¿ Slovakia¿¿¿¿¿¿¿ Turkey¿¿¿¿¿¿¿¿¿ United¿Kingdom¿ Vietnam¿¿¿¿¿¿¿¿
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0101-2021, Z-0102-2021
- ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number
- Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA¿ Chemistry systems Siemens Material Number (SM
Terminated Class II Medical devices
- Recall started
- 28 August 2020
- Terminated
- 9 September 2021
- Reason
- Sporadically inconsistent discrepant (low bias) glucose results on card lot 01-20095-10. Potential exists for a delay in diagnosis of hyperglycemia or unnecessary treatment for hypoglycemia.
- Distribution
- Nationwide Foreign: Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2970-2020
- Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care SMN#
Terminated Class II Medical devices
- Recall started
- 25 August 2020
- Terminated
- 4 May 2023
- Reason
- Low outlier resultsgenerated with Alkaline Phosphatase (ALPI) Flex reagent cartridge.The maximum difference observed with a patient sample was approximately -27% at a concentration of 129 U/L (2.15 ukat/L). The low outlier results are generated from the last five (5) tests of the well
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Australia, Austria, Belgium, Bahamas, Czech Republic, Denmark, France, Germany, Italy, Japan, Korea, Netherlands, Norway, New Zealand, Portugal, Slovakia, Slovenia, Spain, Switzerland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0134-2021
- Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma Catalog Number: K2115, SMN# 1064
Terminated Class II Medical devices
- Recall started
- 25 August 2020
- Terminated
- 10 March 2023
- Reason
- Siemens confirmed that the Upper Limit of Normal (ULN) as claimed in the Instructions for Use (IFU) was no longer achieved. This can potentially result in false positive or false negative results.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0115-2021
- Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI Codes: (01)00630414599151(10)98034139(17)20210130 and (01)00630414599151(10)32478139(17)20210130 Atellica IM HER-2/neu (H2n) calibrator, 2
Terminated Class II Medical devices
- Recall started
- 19 August 2020
- Terminated
- 25 August 2023
- Reason
- Positive bias across the Analytical Measurement Range of the TNIH assay compared to an unaffected control lot. The average bias observed for patient samples using lots EB0255 and EA0178 of the Dimension EXL Troponin compared with a control lot was +25%. A maximum bias of +34% in patient samples around the 99th percentile observed
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0052-2021
- Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma Catalog Number: RF627, SMN# 10471068
Terminated Class II Medical devices
- Recall started
- 24 July 2020
- Terminated
- 7 June 2023
- Reason
- Dimension Vista High Sensitivity Troponin I (TNIH) may exhibit a negative bias with patient samples
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2927-2020
- Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma Catalog Number K6427, SMN# 104471067
Terminated Class II Medical devices
- Recall started
- 30 June 2020
- Terminated
- 17 November 2020
- Reason
- If DCA Vantage Analyzer is configured to run Code 39 with check digit, the scanner is not confirming the integrity of read barcode data using the check digit. Also, if DCA Vantage Analyzer is configured to run Code 39 with check digit and an operator erroneously scans a Code 39 barcode without a check digit, the scanner incorrectly sends the code and the last character is removed.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2747-2020
- DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW external accessory to DCA Vantage Analyzer US
Terminated Class II Medical devices
- Recall started
- 5 June 2020
- Terminated
- 18 November 2021
- Reason
- Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemistry Calibrator lot 534177 for ADVIA Chemistry and lot 534179 for Atellica CH.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2430-2020, Z-2431-2020
- ADVIA Chemistry Calibrator
- Atellica CH Chemistry Calibrator
Terminated Class II Medical devices
- Recall started
- 27 May 2020
- Terminated
- 12 January 2021
- Reason
- The scanner is not confirming the integrity of read barcode data using the check-digit when reading Code 39 barcodes.
- Distribution
- Foreign distribution only.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2432-2020
- RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11416778
Terminated Class II Medical devices
- Recall started
- 15 May 2020
- Terminated
- 18 May 2021
- Reason
- Unexpected interface driver behavior identified (QC) Results May Be Assigned to an Incorrect Control Lot Number, and lead to the reporting of erroneous patient results if the QC failed but appeared to be passing and the issue is not detected during QC review
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Argentina, Australia, Bahamas, Belgium, Brazil, Chile, Colombia, Czech Republic, Egypt, Germany, Greece, Hungary, India, Italy, Kuwait, Latvia, Lithuania, Malaysia, Mexico, Oman, Peru, Poland, Portugal, Qatar, Saudi Arabia,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2437-2020, Z-2438-2020
- (1) CentraLink Data Management System software version 16.0.2 Siemens Material Number (SMN): 11313246 (2) CentraLink Data Management System software version 16.0.3 Siemens Material Number (SMN): 11314337 Product Usage:
- (1) Atellica Data Manager software version 1.0 Siemens Material Number (SMN): 11314237 (2) Atellica Data Manager software version 1.1 Siemens Material Number (SMN): 11316888 Product Usage: are clinical laboratory inf
Terminated Class II Medical devices
- Recall started
- 15 May 2020
- Terminated
- 12 August 2022
- Reason
- Flexible tubing connected to the liquid waste bottle can crack during routine customer maintenance potentially causing liquid waste can leak onto the floor, creating a slip and fall hazard
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of AE, AO, AR, AT, AU, AZ, BA, BD, BE, BG, BH, BO, BR, BS, BY, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GE, GP, GR, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JO, JP, KR, KW, KZ, LB, LT, LU, LV, LY, ME,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2469-2020, Z-2470-2020
- Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #10380062 - Product Usage: are intended for professional use in a laboratory environment only.
- Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SMN #10373214 - Product Usage: are intended for professional use in a laboratory environment only.
Ongoing Class II Medical devices
- Recall started
- 7 May 2020
- Reason
- Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and IM1600 analyzers.
- Distribution
- Worldwide distribution including to the following states: Florida, New Jersey, New York, California, Arizona, Colorado, Pennsylvania, Virginia, Ohio, Texas, Alabama, Nebraska, Wisconsin, Montana, Kentucky, Washington DC, Massachusetts, North Carolina, Georgia, Louisiana, Kansas, South Carolina, Tenn
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2404-2020, Z-2405-2020
- Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960
- Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026
Terminated Class II Medical devices
- Recall started
- 4 May 2020
- Terminated
- 20 September 2021
- Reason
- The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of North Carolina, California, Indiana, Florida, Ohio, Arizona, Massachusetts, New Jersey, New Hampshire, Illinois, Minnesota, Arkansas, New York, Delaware, Nevada, Kentucky, Washington DC, Montana, Missouri, Colorado, Maryl
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2280-2020, Z-2283-2020, Z-2281-2020, Z-2284-2020, Z-2285-2020, Z-2282-2020
- ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941, UDI Number 00630414558073 - Product Usage: use in the quantitative measurement of glycated protein (fructosamine) in human serum and plasma f
- Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number 00630414595795 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and
- Atellica CH Fructosamine Reagent (FRUC), Siemens Material Number 11097637, UDI Number 00630414595580 use in the quantitative measurement of glycated protein (fructosamine) in human serum and plasma for monitoring the blo
- Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number 00842768030512 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and tre
- Dimension Vista Enzymatic Creatinine, Siemens Material Number 10700444, UDI Number 00842768036262 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis a
- ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material Number 10335869, UDI Number 00630414526690 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis
Terminated Class II Medical devices
- Recall started
- 27 February 2020
- Terminated
- 25 October 2021
- Reason
- Editing an assay Test Definition and switching to another assay s Test Definition screen without saving the changes using the save button on the screen, may corrupt the settings of the assay s test definition, and Auto-Rerun or Auto-Dilution results may generate a result of Zero (0) for quantitative assays or Negative for qualitative assays if a well of the reagent pack is not calibrated.
- Distribution
- US Nationwide. Global distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1797-2020
- Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower
Terminated Class II Medical devices
- Recall started
- 14 February 2020
- Terminated
- 22 February 2024
- Reason
- The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval.
- Distribution
- Domestic distribution nationwide. Foreign distribution to Australia, Austria, Bahamas, Belgium, Canada, Curacao, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, India, Israel, Italy, Japan, Kenya, Latvia, Mexico, Netherlands, Norway, Poland, Portugal, Slovakia, South Korea, Spain
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1599-2020
- Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an ethyl alcohol assay, IVD use.
Terminated Class II Medical devices
- Recall started
- 13 February 2020
- Terminated
- 23 April 2021
- Reason
- Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
- Distribution
- Nationwide Foreign: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, U
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1539-2020, Z-1540-2020, Z-1537-2020, Z-1538-2020, Z-1541-2020, Z-1536-2020
- ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 (40 mL) & 10341113 (70 mL). Product Usage: ADVIA TBIL_2 is for in vitro diagnostic use in the quantitative determination of total bilirubin in human serum and
- Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10444957 Product Usage: Dimension TBI method for the ¿ clinical chemistry syst6em is an in vitro
- Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin SMN: 11097531 - Product Usage: Atellica TBil_2 assay is for in vitro diagnostic use in the quantitative determination of
- ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114 (70 mL) - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and pl
- Dimension Vista¿ Total Bilirubin Flex¿ reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10445146 Product Usage: Dimension Vista TBIL method is an in vitro diagnostic test inten
- Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin SMN: 11097532 - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct
Terminated Class II Medical devices
- Recall started
- 5 February 2020
- Terminated
- 18 November 2021
- Reason
- Due to high discordant Estradiol results which.potentially affects all patient populations, A falsely elevated estradiol level could lead a clinician to misinterpret a patient as pre-menopausal when truly post- menopausal. This may lead to delayed initiation of a potentially beneficial drug and/or administration of an unnecessary drug in the treatment for hormone receptor positive advanced or metastatic breast cancer.
- Distribution
- Worldwide distribution - US Nationwide in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, IN, KY, LA, MA, MD, MI, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI. SC, TN, TX, UT, VA, WA, WI, WY, and countries of AE, AF, AL, AO, AR, AT, AU, AZ, BD, BE, BO, BG, BH, BR, CA, CH, CO, CL, CN, CO,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1514-2020, Z-1513-2020
- IMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(D) (200 tests) and L2KE26(D) (600 tests) and OUS: L2KE22 (200 tests), L2KE26 (600 tests) - Product Usage: For in vitro diagnostic use with the IMMULITE systems Ana
- IMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21(D) and OUS: LKE21 - Product Usage: For in vitro diagnostic use with the IMMULITE systems Analyzers for the quantitative measurement of estradiol in serum, as an a
Ongoing Class II Medical devices
- Recall started
- 12 January 2020
- Reason
- Some lots ending in "17", "18", "19", or higher may have cuvette defects allowing water from the water bath to contaminate the interior of the cuvette, which may falsely elevate or depress sample results.
- Distribution
- Domestic distribution nationwide. Worldwide foreign distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1421-2020
- Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143
Terminated Class II Medical devices
- Recall started
- 6 January 2020
- Terminated
- 11 July 2022
- Reason
- A software error is causing the analyzer to incorrectly eject affected Humidity Packs as expired.
- Distribution
- Domestic distribution nationwide. Foreign distribution worldwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1435-2020, Z-1436-2020
- Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Version V1.21.0 and lower - Product Usage: The system is intended for the qualitative and quantitative analysis of various body fluids, using
- Atellica IM Humidity Pack (Qty 1), SMN 11313496, UDI 00630414243726, Software Version V1.21.0 and lower - Product Usage: Product Usage: The system is intended for the qualitative and quantitative analysis of various body
Terminated Class II Medical devices
- Recall started
- 20 December 2019
- Terminated
- 21 December 2020
- Reason
- Firm has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using this product.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CT, FL, GA, IA, KS, MD, MI, NJ, NM, NY, OH, OK, PA, TN, TX, WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1363-2020
- ADVIA Chemistry Lipase, Ref. No. 01984894 B01-4840-01, Siemens Material No. 10311896, UDI 00630414482446 - Product Usage: Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas, such as
Terminated Class II Medical devices
- Recall started
- 18 December 2019
- Terminated
- 25 June 2020
- Reason
- There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology.
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1233-2020, Z-1231-2020, Z-1232-2020, Z-1230-2020
- Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444
- Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533
- Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520
- ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869
Terminated Class II Medical devices
- Recall started
- 19 November 2019
- Terminated
- 30 August 2021
- Reason
- Atellica and ADVIA hsCRP calibrator accuracy has drifted away from the reference materials (ERM-DA470/IFCC), which is causing a high bias on QC and patient sample recovery.
- Distribution
- Worldwide distribution US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, WA, WY and countries of UK, CA, PH, MX, VN, TW, TH, IN, CO, AE, AR, AU, BD, BE, BG, BR, CL,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1260-2020, Z-1261-2020
- ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calibrator - product Usage: For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the CardioPhase¿ hsCRP assay.
- Atellica CH High Sensitivity C-Reactive Protein (HsCRP) Calibrator - Product Usage: For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the CardioPhase¿ hsCRP assay
Terminated Class II Medical devices
- Recall started
- 11 October 2019
- Terminated
- 3 May 2021
- Reason
- On the Atellica CH 930 Analyzer, when scanning barcodes at the module console for Integrated Multisensor Technology (IMT) system fluids (Standard A (Std A) and Standard B (Std B)) for Sodium (Na), Potassium (K), and Chloride (Cl), the system will translate the decimal point separators to commas. This will result in invalid concentration values for the fluids, therefore the system will utilize default nominal values instead of lot specific IMT fluid concentration values for calculation of the calibrations and results for the Na, K, and Cl methods.
- Distribution
- The products were distributed to the following foreign countries: Argentina, Belgium, Brazil, Denmark, Finland, France, Germany, Greece, Italy, Latvia, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, and Vietnam. No affected products distributed in the United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0862-2020
- Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions V1.19.2 or 1.20.0 The Atellica CH 930 Analyzer is an automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests
Terminated Class II Medical devices
- Recall started
- 23 September 2019
- Terminated
- 6 July 2022
- Reason
- Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher.
- Distribution
- Distributed to accounts located in AL AZ AR CA CO FL GA IL IN IA KS KY LA MA MI MN MS NE NV NH NJ NM NY NC OH OR PA SC TN TX UT WA WV DC PR. Foreign distribution to AR AU AT BS BD BE BR BG CA CL CO CW CZ DK EG FI FR DE GR HU IN IR IE IL IT JP KW LV MY MX NL NG NO CN PK PH PL PT QA KR RO RU SA SG SK
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0581-2020
Terminated Class II Medical devices
- Recall started
- 15 August 2019
- Terminated
- 5 May 2022
- Reason
- Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2
- Distribution
- Nationwide Foreign: Argentina Australia Bangladesh Belgium Brazil Colombia Dominican Republic Finland France Germany Greece Italy Japan Latvia Mexico Netherlands P.R. China Republic Korea Singapore Spain Switzerland Thailand United Kingdom Vietnam
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0204-2020, Z-0205-2020
- Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001
- Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000
Terminated Class II Medical devices
- Recall started
- 14 August 2019
- Terminated
- 28 July 2021
- Reason
- Atellica IM anti-CCP IgG (aCCP) Test Definition (TDef) Mitigation Failure-reagent carryover mitigation for the Testosterone II (TSTII) assay is unable to be completed as defined in the aCCP Test Definition (TDef). The issue occurs on an Atellica IM Analyzer and is isolated to TDef Version 1.0. FOR OUS: Atellica IM anti-CCP IgG (aCCP) and Pregnancy-Associated Plasma Protein-A (PAPP-A) Test Definition (TDef) Mitigation Failure
- Distribution
- Worldwide distribution - US Nationwide distribution including the states of CA, FL, KY, NH, TX and countries of Austria¿¿¿¿¿¿¿¿ Curacao,¿St¿Eus Czech¿Republic¿ Denmark¿¿¿¿¿¿¿¿ France¿¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Greece¿¿¿¿¿¿¿¿¿ Italy¿¿¿¿¿¿¿¿¿¿ Poland¿¿¿¿¿¿¿¿¿ Slovakia¿¿¿¿¿¿¿ Sp
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2754-2019
- Atellica IM anti-CCP IgG (aCCP) Assay Siemens Material Number: 10732998 (100 Test) Test Version1.0 - Product Usage: The ADVIA Centaur¿ Anti-CCP IgG (aCCP) assay is for in vitro diagnostic use in the semi-quantitative d
Terminated Class II Medical devices
- Recall started
- 30 July 2019
- Terminated
- 10 June 2022
- Reason
- Atellica CH 930 Analyzer - Erroneous Indices for Hemolysis and Lipemia in Software versions 1.19.2 and below
- Distribution
- Worldwide Distribution - US Nationwide Foreign: Argentina Australia Austria Bangladesh Belgium Brazil Bulgaria Canada Chile Colombia Czech Republic Denmark Ecuador Egypt Finland France Germany Greece Hungary India Indonesia Iran Ireland Israel Italy Japan Kuwait Latvia
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0148-2020
- Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical specimens
Terminated Class II Medical devices
- Recall started
- 22 July 2019
- Terminated
- 14 February 2025
- Reason
- Homocysteine Assay May Cause Elevated Results in the Folate Assay
- Distribution
- Nationwide Foreign: Armenia¿¿¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿ Bahrain¿¿¿¿¿¿¿¿ Belgium¿¿¿¿¿¿¿¿ Bosnia¿Herzeg.¿ Czech¿Republic¿ Denmark¿¿¿¿¿¿¿¿ Egypt¿¿¿¿¿¿¿¿¿¿ France¿¿¿¿¿¿¿¿¿ Georgia¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Greece¿¿¿¿¿¿¿¿¿ Hungary¿¿¿¿¿¿¿¿ Iran¿¿¿¿¿¿¿¿¿¿¿ Ireland¿¿¿¿¿¿¿¿ Israel¿¿¿¿¿¿¿¿¿ Italy¿
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0829-2020, Z-0830-2020, Z-0831-2020
- Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells SMN:10310308
- Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red blood cells SMN: 10325366
- Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in serum or red blood cell SMN: 10331250
Terminated Class II Medical devices
- Recall started
- 15 July 2019
- Terminated
- 12 August 2021
- Reason
- Negative Bias with Lot EA9227.
- Distribution
- Worldwide Distribution AK AR AZ CA CT FL GA IA ID IL IN KS KY LA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2229-2019
- Dimension¿ Ferritin (FERR) Flex¿ reagent cartridge DM FERR Product Usage: The FERR Flex reagent cartridge is intended to be used on the Dimension RxL clinical chemistry system to quantitatively measure ferritin in h
Terminated Class II Medical devices
- Recall started
- 10 July 2019
- Terminated
- 28 May 2024
- Reason
- There is a potential for low discordant progesterone results on a subset of patient samples. A falsely low progesterone result may lead to the consideration for additional progesterone supplementation.
- Distribution
- Global distribution. US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2289-2019, Z-2290-2019
- IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128
- IMMULITE 2000 Progesterone; Models US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2KPW6(D); SMN Numbers US: 10901873, 10901874 and OUS 10381181, 10381170
Terminated Class II Medical devices
- Recall started
- 27 June 2019
- Terminated
- 27 May 2020
- Reason
- Iincreased (falsely elevated) Albumin results compared to expected results
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2341-2019
- N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in serum, plasma, urine and CSF. Siemens Material Number (SMN):10446539
Terminated Class II Medical devices
- Recall started
- 29 May 2019
- Terminated
- 12 May 2022
- Reason
- Potential for increased rate of false positive results and/or increased rate of random non-repeatable false positive results.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2135-2019
- Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as an aid in the d
Terminated Class II Medical devices
- Recall started
- 3 May 2019
- Terminated
- 19 January 2021
- Reason
- A steady upward trend in blank (u) absorbance was observed
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1913-2019, Z-1914-2019
- ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 - Product Usage: The ADVIA¿ Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative dete
- Atellica CH Creatine Kinase (CK_L) Reagent, Product Code 11097640, UDI Number: 00630414006642 - Product Usage: The ADVIA¿ Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determin
Terminated Class II Medical devices
- Recall started
- 7 March 2019
- Terminated
- 20 August 2020
- Reason
- There were multiple issues identified in the system software which required an update.
- Distribution
- The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, NC, NE, NH, NM, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, WA, WV, WY, and Puerto Rico. The products were distributed to the following foreign countries: Argentina, Austr
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1300-2019, Z-1301-2019, Z-1299-2019
- Atellica IM 1600 Analyzer, Material Number 11066000
- Atellica Sample Handler Prime, Material Number 11069001
- Atellica IM 1300 Analyzer, Material Number 11066001
Terminated Class II Medical devices
- Recall started
- 12 December 2018
- Terminated
- 27 April 2020
- Reason
- When the Millipore Water Purification Module Progard Pretreatment Packs are used with Dimension Vista Triglyceride assay, patient and QC triglyceride results may be erroneously elevated as a result of contamination.
- Distribution
- Nationwide domestic distribution. Worldwide foreign distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1015-2019, Z-1014-2019
- Dimension Vista 1500, Analyzer, chemistry Model no. 10444801
- Dimension Vista 500, Analyzer, chemistry Model no. 10284473
Terminated Class II Medical devices
- Recall started
- 7 December 2018
- Terminated
- 27 April 2020
- Reason
- Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atellica IM aTG kit lots ending in 317 and lower when compared to the standardization to World Health Organization (WHO) Reference Preparation MRC 65/93 stated in the Instructions for Use (IFU).
- Distribution
- Nationwide Foreign: Belgium¿¿¿¿¿¿¿¿ Croatia¿¿¿¿¿¿¿¿ Czech¿Republic¿ Denmark¿¿¿¿¿¿¿¿ France¿¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Greece¿¿¿¿¿¿¿¿¿ Ireland¿¿¿¿¿¿¿¿ Italy¿¿¿¿¿¿¿¿¿¿ Poland¿¿¿¿¿¿¿¿¿ Portugal¿¿¿¿¿¿¿ Slovakia¿¿¿¿¿¿¿ Spain¿¿¿¿¿¿¿¿¿¿ Switzerland¿¿¿¿ Turkey¿¿¿¿¿¿¿
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1234-2019, Z-1235-2019, Z-1236-2019, Z-1233-2019
- SiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399
- Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461
- Atellica IM aTG (500 test kit) Siemens Material Number (SMN): 10995462
- Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 10492398
Terminated Class II Medical devices
- Recall started
- 16 October 2018
- Terminated
- 17 June 2020
- Reason
- Siemens Healthcare Diagnostics has identified an issue with Dimension Vista software v.3.7 and v.3.8.1 that may result in aliquot well contamination. If a test is cancelled by the operator while the instrument is aliquotting the sample, the Dimension Vista instrument may continue to deliver the cancelled sample or vial contents to the aliquot well(s). Future samples may be assigned to the same aliquot well(s) and become contaminated with the existing contents or overflow of the aliquot well may occur potentially contaminating a surrounding well(s). This issue only occurs when an operator manually cancels a test(s) for calibration, quality control (QC) or patient sample while the instrument is in the process of aliquotting the sample.
- Distribution
- Nationwide/worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0616-2019, Z-0617-2019
- Dimension Vista 500, model no. 10284473 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of an
- Dimension Vista 1500, Model No. 10444801 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of a
Terminated Class II Medical devices
- Recall started
- 11 October 2018
- Terminated
- 29 June 2020
- Reason
- Siemens Healthcare Diagnostics has confirmed that Dimension Vista Lactate Dehydrogenase (LDI) may exhibit an erroneously elevated result when the preceding assay in the reaction cuvette is Lactic Acid (LA). The magnitude of the elevation may be variable. Both quality control and patient samples may be impacted. Incomplete removal of residual lactate dehydrogenase, a component of the LA reagent, has been identified as the cause of the potentially elevated result. A falsely elevated result for lactate dehydrogenase may lead to additional investigations to determine the etiology of tissue damage. Results would be correlated with clinical history and presentation in addition to other diagnostic laboratory testing.
- Distribution
- Worldwide-domestic nationwide and foreign distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0499-2019
- Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vitro diagnostic test for the quantitative measurement of lactate dehydrogenase in human serum and plasma on the Dimension Vista¿ System.Cat. No.
Terminated Class II Medical devices
- Recall started
- 28 September 2018
- Terminated
- 17 June 2020
- Reason
- Thermal chamber motors have electrical cables with single insulation rather than the required double insulation. There is no exposed current due to the single insulation that could result in a potential electrical shock
- Distribution
- Worldwide Distribution: US (Nationwide) and countries of: Algeria, Argentina, Australia, Brazil, Canada, China, Columbia, Croatia, Egypt, France, Germany, Great Britain, Greece, Hungary, India, Italy, Japan, Malaysia Mexico, Netherlands, Poland, Portugal, Russia, Saudi Arabia, Slovenia, South Africa
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0409-2019
- Dimension Thermal Chamber Motor Cable located in the following models: Model/UDI Number: Dimension¿ EXL 200 00630414593579; Dimension¿ EXL with LM 00630414593500; Dimension¿ EXL with LM with STM 00630414593593; Dime
Terminated Class II Medical devices
- Recall started
- 26 September 2018
- Terminated
- 24 June 2020
- Reason
- Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica¿ IM 1300 Analyzer Atellica¿ IM 1600 Analyzer;Atellica¿ CH 930 Analyzer; Atellica¿ Sample Handler Prime
- Distribution
- Worldwide distributions - US Nationwide and countries of Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, Nigeria, Norway, P.R. Chin
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0782-2019, Z-0780-2019, Z-0781-2019, Z-0783-2019
- Atellica CH 930 Analyzer. In vitro diagnostic testing of clinical specimens Siemens Material Number (SMN): 1 067000 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of
- Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens. Siemens Material Number (SMN): 1066001 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of
- Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intend
- Atellica Sample Handler Prime. In vitro diagnostic testing of clinical specimens - Siemens Material Number (SMN): 11069001 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic test
Terminated Class II Medical devices
- Recall started
- 7 September 2018
- Terminated
- 16 November 2020
- Reason
- There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots.
- Distribution
- Worldwide - US Nationwide Distributions The products were distributed to the following foreign countries: Argentina, Australia, Bangladesh, Brazil, Canada, Chile, China, Colombia, Germany, Ecuador, Honduras, Indonesia, India, Japan, Republic of Korea, Mexico, Malaysia, Nicaragua, New Zealand, P
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0466-2019, Z-0465-2019
- Dimension Vista Lipase Flex Reagent Cartridge, Model Number 10461745 Product Usage: Dimension Vista - The LIPL method is an in vitro diagnostic test for the quantitative measurement of lipase in human serum and plasm
- Dimension Lipase Flex Reagent Cartridge, Model Number 10460277 Product Usage: Dimension - The LIPL method is an in vitro diagnostic test for the quantitative measurement of lipase in human serum and plasma on the Dim
Terminated Class II Medical devices
- Recall started
- 14 August 2018
- Terminated
- 4 September 2020
- Reason
- The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
- Distribution
- The products were distributed to the following US states: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, VA, WA, and WV. The products were distributed to the following foreign countries: Australia, Aust
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0212-2019, Z-0210-2019, Z-0215-2019, Z-0209-2019, Z-0216-2019, Z-0217-2019, Z-0214-2019, Z-0213-2019, Z-0211-2019
- APTIO 15000 REFRIGERATED STORAGE MODULE
- APTIO RACK INPUT MODULE
- STREAMLAB CORE UNIT / LYNX WITH IOM
- APTIO INPUT/OUTPUT MODULE
- STREAMLAB - REFRIGERATED STORAGE MODULE 9000
- STREAMLAB - REFRIGERATED STORAGE MODULE 15000
- APTIO RACK OUTPUT MODULE
- APTIO 9000 REFRIGERATED STORAGE MODULE
- and 1 more product lines
Terminated Class II Medical devices
- Recall started
- 24 July 2018
- Terminated
- 26 May 2020
- Reason
- A potential bias was identified with certain kits compared to the internal standards.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0116-2019, Z-0113-2019, Z-0117-2019, Z-0115-2019, Z-0114-2019
- Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point
- ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
- Atellica IM CKMB Master Curve Material, Cat No. 10995534 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a
- ADVIA Centaur CKMB Master Curve Material, Cat No. 07867768 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after
- ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.
Terminated Class II Medical devices
- Recall started
- 16 July 2018
- Terminated
- 23 June 2020
- Reason
- Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDLab Blood Gas systems indicated. This may cause lower than expected values for carboxyhemoglobin (fCOHb) and methemoglobin (fMetHb). A negative interference with fCOHb has the potential to alter the medical assessment of the patient and may withhold necessary follow-up treatment and/or initiate cessation of medication in response to elevated fMetHb levels.
- Distribution
- Nationwide distribution. Worldwide foreign distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2930-2018, Z-2929-2018, Z-2928-2018, Z-2927-2018
- RAPIDLab 1265 Blood Gas Analyzer; 110321852, 10470366, 10491395 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate,
- RAPIDLab 1245 Blood Gas Analyzer; 10321844, 10337179, 10491393 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate,
- RAPIDPoint 500 Blood Gas Analyzer; 10492730, 1069855, 10696857, 10697306 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose,
- RAPIDPoint 405 Blood Gas Analyzer; 10282093, 10310464, 10314817, 10317193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784 Device is point-of-care system for comprehensive lab-quality testing to
Terminated Class II Medical devices
- Recall started
- 29 June 2018
- Terminated
- 12 August 2021
- Reason
- Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks¿ and Ancillary Packs when more than one (1) lot of specific Reagent kits are loaded on the analyzer at the same time. 2. Sample barcodes may be incorrectly read 3. The Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer may not run CEA dilutions at 50x and 100x. The Analyzer may post a Sample Integrity Error when 50x or 100x dilutions are ordered for Carcinoembryonic Antigen (CEA). Dilution factors lower than 50x and neat samples are not affected by this behavior. 4. The Atellica CH 930 Analyzer may continue to display the default reporting units after the reporting units have been changed. 5. The Atellica CH 930 Analyzer may not display results for sample if certain assays are configured to auto-dilute results above or below the assay measuring interval.
- Distribution
- Nationwide Foreign: Australia Austria Belgium Brazil Canada Croatia Czech Republic Denmark France Germany Greece Italy Japan Malaysia Mexico Netherlands Norway Poland Republic Korea Singapore Spain Sweden Switzerland U.A.E. United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0189-2019, Z-0193-2019, Z-0191-2019, Z-0190-2019, Z-0194-2019, Z-0192-2019
- Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
- Atellica IM 1600 Analyzer (SMN 11066000). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
- Atellica Sample Handler Additional (SMN 11069004). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
- Atellica Sample Handler Connect (SMN 11069018). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
- Atellica CH 930 Analyzer (SMN 11067000) . The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
- Atellica IM 1300 Analyzer (SMN 11066001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
Terminated Class II Medical devices
- Recall started
- 19 April 2018
- Terminated
- 24 April 2020
- Reason
- The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end of the Analytical Measurement Range. The bias is due to the calibration curve not showing separation between the Level 1 and Level 2 calibrators.
- Distribution
- Nationwide distribution. Foreign distribution to Argentina, Australia, Brazil, Bahamas, Canada, Germany, India, Japan, Myanmar, New Zealand, Saudi Arabia, Taiwan, and South Africa.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2181-2018, Z-2182-2018
- Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers affected are EB8115, BB8159, and FB8275.
- Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme immunoassay. Affected lots are 17135BC, 17150BF, 17159BD, 17178AC, 17269BD, and 17312BB.
Terminated Class II Medical devices
- Recall started
- 27 March 2018
- Terminated
- 3 February 2021
- Reason
- Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Results cannot be generated by the system when calibration fails.
- Distribution
- Nationwide and worldwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2062-2018
- ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems
Terminated Class II Medical devices
- Recall started
- 21 March 2018
- Terminated
- 12 June 2020
- Reason
- The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective septum has the potential to cause erroneously elevated results if a sample is autodiluted onboard the system, due to a reduced volume of diluent being pipetted from the vial.
- Distribution
- The products were distributed to the following US states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The products were distributed to
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2438-2018, Z-2437-2018, Z-2436-2018
- Dimension Vista¿ MULTI 2 SDIL, KD694, SMN# 10483586
- Dimension Vista¿ MULTI 1 SDIL, KD693, SMN# 10469971
- Dimension Vista¿ CTNI Sample Diluent, KD692, SMN# 10445205
Terminated Class III Medical devices
- Recall started
- 12 March 2018
- Terminated
- 2 June 2020
- Reason
- Incorrect calibrator level listed in qualitative calibration steps
- Distribution
- PA, MA, TX, ME, UT, FL, KS, NH, KY and Foreign
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1800-2018, Z-1799-2018
- Syva¿ EMIT¿ II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 10470440
- Syva¿ EMIT¿ II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10481483
Terminated Class II Medical devices
- Recall started
- 26 February 2018
- Terminated
- 12 May 2020
- Reason
- When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers
- Distribution
- FL and France Spain Sweden United Kingdom Germany
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1588-2018, Z-1586-2018, Z-1587-2018
- Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens.
- Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens.
- Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens.
Terminated Class II Medical devices
- Recall started
- 21 February 2018
- Terminated
- 16 May 2019
- Reason
- Upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the assay instructions for use.
- Distribution
- US Nationwide, and the following countries: Albania, Angola, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia Herzegovina, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, F
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1486-2018
- ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/500 tests)
Terminated Class II Medical devices
- Recall started
- 30 January 2018
- Terminated
- 16 May 2019
- Reason
- May produce erroneously low results from specific well sets.
- Distribution
- Worldwide Distribution - USA (nationwide) and to the following countries: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Japan, Norway, Portugal, Slovakia, Slovenia, South Korea, Spain, Switzerland
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1540-2018
- Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023, SMN # 10445160 The CA method is an in vitro diagnostic test for the quantitative measurement of calcium in human serum, plasma, and urine o
Terminated Class II Medical devices
- Recall started
- 2 January 2018
- Terminated
- 10 February 2023
- Reason
- Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.
- Distribution
- Nationwide and Canada, Mexico, and Thailand
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1691-2018, Z-1680-2018, Z-1677-2018, Z-1682-2018, Z-1688-2018, Z-1681-2018, Z-1675-2018, Z-1669-2018, Z-1672-2018, Z-1690-2018, Z-1678-2018, Z-1679-2018 and 12 more
- IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi BR-MA (CA15-3)
- IMMULITE ¿ /IMMULITE 1000 ¿ Gastrin
- IMMULITE ¿ /IMMULITE ¿ 1000 BR-MA (CA15-3)
- IMMULITE ¿ /IMMULITE ¿ 1000 OM-MA (CA125)
- ADVIA Centaur¿ DHEA-SO4
- IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Gastrin
- IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Anti HBc
- Dimension¿ Free Thyroxine (FT4L) Flex¿ reagent cartridge
- and 16 more product lines
Ongoing Class II Medical devices
- Recall started
- 18 December 2017
- Reason
- In certain scenarios the ADVIA Centaur CP, XP and XPT immunoassay analyzers may exhibit reduced dilution recovery or become inoperable when used with Multi-Diluent 15 and certain lots of BNP and TSH3RUL Assays.
- Distribution
- Distributed in the following U.S. states: AL, CA, DE, GA, IA, IL, IN, KY, MA, MI, MS, MT, NC, ND, NJ, NM, NV, NY, OH, PA, RI, TN, TX, VA, WA, WV, WY and Puerto Rico. Distributed in the following OUS countries: Australia Belgium¿¿¿¿¿¿¿¿ Canada Chile France¿¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Greece¿¿¿¿¿¿¿
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2054-2018, Z-2053-2018
- ADVIA Centaur TSH3-Ultra (Thyroid Stimulating Hormone 3 Ultra), Catalog Numbers: 06491072 (100 tests), 06491080 (500 tests), 04862625 (2500 tests)
- ADVIA Centaur BNP (B-type Natriuretic Peptide), Catalog Numbers: 02816138 (100 tests), 02816634 (500 tests)
Terminated Class II Medical devices
- Recall started
- 14 December 2017
- Terminated
- 3 December 2020
- Reason
- Calibration failure - confirmed a positive bias with LIPL lot FB8109 when compared to other Dimension LIPL lots. Lot FB8109 is not meeting Siemens internal specifications for lot-to-lot limits.
- Distribution
- Domestic and Foreign consignees
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1796-2018
- Dimension Lipase Flex¿ Reagent Cartridge - ( Lipase-esterase, enzymatic, photometric, lipase)
Terminated Class II Medical devices
- Recall started
- 27 November 2017
- Terminated
- 19 April 2019
- Reason
- Lot J1 of the Syva¿ EMIT¿ 2000 Theophylline Assay, when run on a Beckman AU Clinical Chemistry System, may exhibit increased imprecision for commercially available controls and for patient samples.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1946-2018
- Syva¿ EMIT¿ 2000 Theophylline Product Usage: The Syva¿ Emit¿ 2000 Theophylline Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma.
Terminated Class II Medical devices
- Recall started
- 9 November 2017
- Terminated
- 8 June 2020
- Reason
- An increase in the number of failed calibration events or negative bias with Quality Control (QC) and patient samples when using Dimension Vista LOCI 8 Calibrator lot 7CD076 to calibrate Estradiol (E2) Assay.
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: Austria, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Slovakia, Spain and Switzerland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1184-2018
- Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in vitro diagnostic product for the calibration of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL), and estradiol (E2
Terminated Class II Medical devices
- Recall started
- 17 October 2017
- Terminated
- 4 November 2019
- Reason
- The BC Thrombin Reagent kit lot 46751 (contains Thrombin Reagent lot 517468) and kit lot 47184 (contains Thrombin Reagent lot 517469) produce unexpected prolonged Thrombin Time (TT) results for expected normal samples, and may recover above the upper limit of normal (< 21 sec.) as stated within the IFU (Instruction For Use).
- Distribution
- Worldwide distribution. US nationwide, Austria, Belgium, Bosnia-Herzegovina, Croatia, Finland, France (incl. Guadeloupe, Martinique, Reunion, French Guinea overseas departments), Germany, Greece, Hungary, Italy, Kazakhstan, Macedonia, Latvia, Poland, Portugal, Qatar, Russian Federation, Saudi Arabi
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0827-2018
- BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and BC Thrombin Reagent Kit Lot Number 47184; UDI -008427680131024718420190221; BC Thrombin Reagent; Test, Thrombin Time Product Usage:
Terminated Class II Medical devices
- Recall started
- 28 July 2017
- Terminated
- 3 April 2019
- Reason
- Siemens has identified an issue when scanning the 20 barcode for the Master Curve Card (MCC) with ADVIA Centaur systems T3 kit lots ending in 198 on the ADVIA Centaur XPT system.
- Distribution
- Worldwide Distribution - US Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0720-2018
- ADVIA Centaur¿ T3 ADVIA Centaur T3: For in vitro diagnostic use in the quantitative determination of triiodothyronine (T3) in serum using the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systems. Measurement
Terminated Class II Medical devices
- Recall started
- 29 June 2017
- Terminated
- 23 April 2020
- Reason
- Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.
- Distribution
- Distributed in all 50 U.S. states, the District of Columbia, Guam, and Puerto Rico. Distributed in 108 foreign countries: Afghanistan Bolivia Albania¿¿¿¿¿¿¿¿ Algeria¿¿¿¿¿¿¿¿ Angola ARGENTINA Armenia AUSTRALIA Austria¿¿¿¿¿¿¿¿ Azerbaijan Bahamas Bahrain¿¿¿¿¿¿¿¿ Bangladesh¿¿¿¿¿ Belarus¿¿
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1647-2018, Z-1660-2018, Z-1654-2018, Z-1646-2018, Z-1651-2018, Z-1648-2018, Z-1652-2018, Z-1649-2018, Z-1659-2018, Z-1662-2018, Z-1657-2018, Z-1661-2018 and 5 more
- ADVIA Alanine Aminotransferase (ALT) reagent chemistry assays; ALT intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and
- Dimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
- Dimension Thyroxine (T4) assay (Product Number: DF65/10444908) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
- ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (heparin or EDTA). Product Number: 10286035 (Mfr: Randox Laboratories)
- Dimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444959) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
- ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative determination of salicylate in human serum and plasma (lithium heparin). Product Number: 10327382 (Mfr: Sekisui Diagnostics)
- Dimension Glucose (GLUC) assay (Product Number: DF40/10444973) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
- Dimension Ammonia (AMM) assay; (Product Number: DF119/10711991) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
- and 9 more product lines
Terminated Class II Medical devices
- Recall started
- 7 June 2017
- Terminated
- 8 May 2019
- Reason
- Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur Enhanced Estradiol (eE2) on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT systems when calibrating with Calibrator 30 kit lots ending in 21 (C3021) as compared to Calibrator 30 kit lots ending in 20 (C3020).
- Distribution
- US and OUS.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0515-2018
- ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number (SMN): 10379810, 10379811, 10697756.
Terminated Class II Medical devices
- Recall started
- 26 August 2015
- Terminated
- 24 March 2020
- Reason
- Software Issues.
- Distribution
- Worldwide distribution - US Nationwide and countries of Japan, Germany, Belgium, France, Italy, Slovakia, Bahamas, United Kingdom and Mexico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1195-2019
- syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical system that assists medical laboratory professions with pre-analytic and post-analytic functions. It works in conjunction with multiple
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.