Bedford, MA, United States
Instrumentation Laboratory recalls
18 recalls recorded since 2018, most recently on 3 September 2026. 15 are listed as ongoing. Status and classification are as published by the FDA.
Recalls18
Ongoing (FDA)15
Terminated or completed3
Class I (FDA)1
Ongoing Class I Medical devices
- Recall started
- 3 September 2026
- Reason
- Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
- Distribution
- Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, FL, GA, MA, MD, NJ, NY, PA, RI, TN, WA, WV and the countries of Austria, Belgium, Switzerland, Costa Rica, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, India, Italy, Jordan, Japan, South Kore
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0002-2027, Z-0001-2027
- HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)
- HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic
Ongoing Class II Medical devices
- Recall started
- 21 May 2026
- Reason
- The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.
- Distribution
- Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, KY, MN, MO, MT, OH, PA, VA, WI, WV and the countries of China, Germany, Italy.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2900-2026, Z-2899-2026
- GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360010.A
- GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 00077430010 Product Description: The GEM Premier 7000 with iQM3 is a portable critical care system for u
Ongoing Class II Medical devices
- Recall started
- 8 May 2026
- Reason
- Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2825-2026, Z-2823-2026, Z-2824-2026, Z-2822-2026, Z-2821-2026, Z-2826-2026
- Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system
- Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
- Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
- Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Intelligent Quality Management 3 (iQM3) is used as the quality control (QC) and assessment system for the
- GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Portable blood analyzer system. Affected Accessory: Bar Code Reader (BCR) Wand Part N
- Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system
Ongoing Class II Medical devices
- Recall started
- 20 January 2026
- Reason
- Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Bulgaria, Brazil, Belarus, Switzerland, Canada, Chile, China, Colombia, Czech Republic, Germany, Denmark, Dominican Republic, Ecuador, Estonia, Spain, Finland, France, United Kingdom, Georgia, Greece,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1524-2026, Z-1533-2026, Z-1539-2026, Z-1538-2026, Z-1534-2026, Z-1531-2026, Z-1527-2026, Z-1529-2026, Z-1542-2026, Z-1530-2026, Z-1525-2026, Z-1541-2026 and 8 more
- GEM Premier 5000 PAK, Part No. 00055360004.
- GEM Premier 5000; Part No. 00055415005.
- GEM Premier 5000; Model No. 00055430010.
- GEM Premier 5000; Part No. 00055430008.
- GEM Premier 5000; Part No. 00055415008.
- GEM Premier 5000 PAK; Part No. 00055407511.
- GEM Premier 5000 PAK; Part No. 00055360011.
- GEM Premier 5000 PAK; Part No. 00055407508.
- and 12 more product lines
Ongoing Class II Medical devices
- Recall started
- 11 December 2025
- Reason
- Potential for microbial contamination.
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, FL, IL, MN, MS, NE, OH, TX, WI and the countries of Belgium, Netherlands, Luxembourg, Switzerland, China, Hong Kong, Israel, Italy, South Korea, Lithuania, Macao, Malaysia, Philippines, Qatar, Romania, Turkey, Kosovo.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1095-2026
- The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
Ongoing Class III Medical devices
- Recall started
- 18 November 2025
- Reason
- Recalled lots were manufactured with double the amount of preservative concentration.
- Distribution
- Domestic: CA, CO, FL, NY; Foreign: AR, AT, CA, CZ, DE, DK, ES, FR, GB, IE, IL, IN, IT, JP, LK, NL, PL, PT, RO, RS, TH, VN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0938-2026
- HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Ongoing Class II Medical devices
- Recall started
- 3 February 2025
- Reason
- Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range when testing is performed with HemosIL Liquid Anti-Xa and HemosIL Heparin Calibrator. In some complaints, failure to pass QC resulted in patient testing delays.
- Distribution
- Worldwide - US Nationwide and the countries of Algeria, Andorra, Argentina, Australia, Austria, Belarus, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Finland, Germany, Gibraltar, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, J
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2323-2025
- HemosIL LMW Heparin Controls; Part Number: 0020300200;
Ongoing Class II Medical devices
- Recall started
- 18 December 2024
- Reason
- Control indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range.
- Distribution
- Worldwide - US Nationwide and the countries of Andorra, Algeria, Armenia, Australia, Austria, Belarus, Belgium, Brazil, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Cyprus, Czechia, Denmark, Finland, France, Georgia, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Iran (Islamic Repub
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1020-2025
- HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
Ongoing Class II Medical devices
- Recall started
- 29 September 2023
- Reason
- Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2 levels less than 60 mmHg) that are outside of labeled performance specifications for pO2. The positive bias may lead to false positive for medical decision levels at pO2 < 60 mmHg, which may result in failure to detect and/or adequately treat hypoxemia and lead to a delay in treatment. The quality control procedures for the Non-iQM GEM Premier 3000 may not detect the non-conformance.
- Distribution
- US States: MA, MN, NY. India.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0358-2024, Z-0357-2024, Z-0359-2024
- GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007
- GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004
- GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Numbers 00024315009, 00024330009, 00024345009, 00024360009
Ongoing Class II Medical devices
- Recall started
- 13 July 2023
- Reason
- Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Finland, Ireland, Lithuania, Malta, Qatar, Sweden.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2578-2023
- ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis
Ongoing Class II Medical devices
- Recall started
- 3 February 2023
- Reason
- Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Albania, Algeria, Australia, Austria, Azerbaijan, Belarus, Belgium, Brazil, Bulgaria, Cape Verde, China, Colombia, Czech Republic, Egypt, Falkland Islands, Finland, France, Georgia, Germany, Ghana, Greece, Hong Kong, Hungary, Ind
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1306-2023, Z-1305-2023, Z-1304-2023, Z-1307-2023
- ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311R
- ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311
- ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311
- ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311R
Ongoing Class II Medical devices
- Recall started
- 8 April 2022
- Reason
- Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots from the market and convert customers to an alternative prothrombin time (PT) reagent, specifically HemosIL RecombiPlasTin 2G.
- Distribution
- US Nationwide distribution including in the states of AZ, CA, IA, IL, IN, KS, MD, ME, MI, MN, MO, NC, NE, NY, OH, OK, SC, TX, VA, WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1052-2022
- HemosIL ReadiPlasTin, Part No. 0020301400
Ongoing Class II Medical devices
- Recall started
- 22 February 2022
- Reason
- Updated and revised user instructions issued 7/14/22. Potential carryover issue may cause elevated quality control and sample results for heparin, apixaban or rivaroxaban when HemosIL Liquid Anti-Xa reagent is used in the same run with both HemosIL Liquid Antithrombin and HemosIL Q.F.A. Thrombin (Bovine), specific to instrument models that utilize a single reagent probe
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belarus, Belgium, Bermuda, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Ecuador, El Salvador, France, Germany, Gibraltar, Great Britain, Greece, Guatemala, Guyana, Hong Kong, H
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1014-2022
- ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1.ACL TOP 300 CTS 00000280060 2. ACL TOP 300 CTS 00000280060R (Refurbished) 3. ACL TOP 350 CTS 00000280065 4. ACL TOP 500 CTS 00000280040 5. ACL
Ongoing Class II Medical devices
- Recall started
- 13 October 2021
- Reason
- The firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls, and prolonged sample results. If quality controls are not performed or do not pass for each vial of reagent, there is a potential risk of reporting an erroneous result.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AZ, CA, IA, IL, KS, ME, MI, NC, NY, OK, SC, and VA. The countries of Canada, Chile, China, Costa Rica, Italy, Japan, and South Korea. ***Updated 3/3/22*** Expansion includes states of IN, MN, and NC.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0276-2022
- HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.
Ongoing Class II Medical devices
- Recall started
- 25 August 2021
- Reason
- Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days
- Distribution
- US Nationwide Foreign: Canada Armenia Austria Australia Belgium Brunei Brazil Belarus Switzerland China Colombia Czech Republic Germany Denmark Spain Finland France United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0151-2022, Z-0150-2022, Z-0149-2022
- HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems,
- HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories. The assay provides quantitative results on 3.2% citrated human plasma Part Number:
- HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems,
Terminated Class II Medical devices
- Recall started
- 23 July 2019
- Terminated
- 27 April 2020
- Reason
- Prolonged clotting times
- Distribution
- States: IL WI MI Canada, Spain, Portugal, Poland, Italy, Israel, Switzerland, Denmark, Kazakhstan, United Kingdom, Germany, Netherlands, Belgium, France, Jordan, India, Hong Kong, Austria, Czechia, Australia, Sri Lanka, Argentina, Vietnam, Singapore, Japan, South Korea, Cyprus, Ireland, Hungar
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2486-2019, Z-2487-2019, Z-2485-2019
- ROTEM ex-tem Canada Part No: 503-05-CA
- ROTEM ex-tem Rest of the world part No: 503-05 (ROW)
- ROTEM ex-tem; US Part No: 503-05-US
Terminated Class II Medical devices
- Recall started
- 1 August 2018
- Terminated
- 16 April 2019
- Reason
- There is a potential for increased imprecision, out of range quality controls and prolonged sample results.
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0077-2019
- Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL¿ ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determin
Terminated Class II Medical devices
- Recall started
- 2 August 2017
- Terminated
- 29 March 2019
- Reason
- Instrumentation Laboratory Co. received customer reports of performance issues with some vials of Lot Nos. N1166235 and N0177760, including increased imprecision, out of range quality controls and prolonged sample results.
- Distribution
- Worldwide Distribution - US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0895-2018
- Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400
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.