Indianapolis, IN, United States
Roche Diagnostics Operations, Inc. recalls
33 recalls recorded since 2018, most recently on 20 January 2026. 11 are listed as ongoing. Status and classification are as published by the FDA.
Recalls33
Ongoing (FDA)11
Terminated or completed22
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 20 January 2026
- Reason
- Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. Cobas pro integrated solutions is an automated analyzer, intended for running qualitative, semi-quantitative and quantitative clinical chemistry and immunochemistry assays, as well as ion-selective measurements. When an erroneous calibration is active, the instrument fails to calculate new values and instead repeats the last successfully calculated result from any Spline-type assay for all subsequent measurements, leading to identical and erroneous patient and QC results. The defect could lead to patients receiving erroneous lab results, which could result in a remote risk of serious adverse health consequences. The following assays use spline type calibration and are affected by this issue: Cystatin C Gen.2, Ferritin Gen.4, Lipoprotein (a) Gen. 2, Lipoprotein (a) molarity, Vancomycin Gen.3, Kappa Free Light Chains Partner Channel, Lambda Free Light Chains Partner Channel, and fCAL turbo Partner Channel.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1476-2026
- cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001 cobas pro SSU, material number 09205632001 Affected Assays: (Product Name/ Catalog Num
Ongoing Class II Medical devices
- Recall started
- 21 November 2025
- Reason
- Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment.
- Distribution
- US Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, ME, MI, MN, NC, NJ, NM, NY, OH, PA, PR, TN, TX, UT, WA, WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1009-2026
- The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Patient serum sample is incubated with pretreatment reagent PT1 a
Ongoing Class II Medical devices
- Recall started
- 17 October 2024
- Reason
- Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)
- Distribution
- US: NJ, TX, NY, FL, IN, TX, OK, SC, IA,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0489-2025
- cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
Ongoing Class II Medical devices
- Recall started
- 15 August 2024
- Reason
- Creatine Kinase (CK) Assay Abnormal calibrations on the cobas¿ c 311/501/502 and COBAS INTEGRA 400 plus Analyzers may lead to erroneous results and misdiagnosis.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3187-2024
- Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination of creatine kinase (CK) in human serum and plasma. Catalog Number: 07190794190
Ongoing Class II Medical devices
- Recall started
- 3 October 2023
- Reason
- Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0352-2024
- Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; INTEGRA 400 plus), 08105618190 - (cobas c 303 and 503)
Ongoing Class II Medical devices
- Recall started
- 12 December 2022
- Reason
- A complaint investigation revealed that an incorrect behavior relating to the rejection of orders capability of the Host Connectivity Agent (HCA) could occur where the order received from the Laboratory Information System (LIS) is created with an Internal ID rather than the External ID sent from the LIS. The erroneous event occurs under rare circumstances where the date in the sample's barcode does not match the order date sent from the LIS, and can lead to the order being mismatched to an another patient's sample ID rather than the subject patient's sample ID. The software bug impacts multiple cobas infinity central lab software (versions 2.5.x , 3.01.x, 3.02.x, and 3.03.x) and occurs when the afflicted software has been configured with specific pre-conditions.
- Distribution
- Domestic distribution nationwide. Foreign distribution pending.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0952-2023
- cobas infinity central lab, Material Number 07154003001
Ongoing Class II Medical devices
- Recall started
- 14 July 2022
- Reason
- Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The following assays are considered impacted by the issue: Anti-HAV2, Anti-HBc IgM, IGF-1, Myogloin, Rubella IgG, and Toxo IgG.
- Distribution
- US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY, DC & PR.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1515-2022
- cobas e801 Immunoassay Analyzer
Terminated Class II Medical devices
- Recall started
- 18 October 2021
- Terminated
- 31 May 2023
- Reason
- A potential risk for false negative nitrite results exists when endogenous creatinine levels are 15,000 mg/L and above. No interference of Nitrite results was observed at creatinine levels up to 9,000 mg/L.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0266-2022
- Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 601 urinalysis test system is comprised of the cobas u 601 urine analyzer and the cobas u pack. The cobas u 601 urine analyzer when used with th
Terminated Class II Medical devices
- Recall started
- 24 June 2021
- Terminated
- 21 July 2023
- Reason
- Under specific circumstances created by the user, the cobas e flow test results could be replaced by an automatic result sent to the lab LIS. This automatic result could be released and interpreted by your Laboratory Information System (LIS) as a false positive or negative result. It should be noted that the "correct" result would still be available on the instrument.
- Distribution
- US Nationwide distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2444-2021
- cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
Ongoing Class II Medical devices
- Recall started
- 26 April 2021
- Reason
- Roche received several complaints regarding increased control recovery and discrepant elevated results for the Iron Gen.2 (IRON2) assay on the cobas c311, 501, and 502 analyzers and on the COBAS Integra 400 plus analyzer.
- Distribution
- US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, 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, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1675-2021
- IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for the quantitative determination of iron in human serum and plasma on Roche/Hitachi cobas c and cobas In
Ongoing Class II Medical devices
- Recall started
- 7 April 2021
- Reason
- Recall reason is possible sporadic false negative conventional troponin results. Roche has confirmed an issue with running Elecsys Troponin I/Troponin I STAT and Elecsys proBNP II/proBNP II STAT on the cobas e 601 and 602 modules. When the proBNP II analyte is measured immediately before the Troponin I analyte on the same module, a decreased recovery on Troponin I was observed.
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, CT, FL, GA, ID, IL, IN,KS, KY, MD, ME, MO, NC, NE, NJ, NM, NY, OH, OK, SC, SD, TN, TX, VA, WA, WY.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1595-2021, Z-1596-2021
- Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
- Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
Terminated Class II Medical devices
- Recall started
- 6 January 2021
- Terminated
- 28 February 2024
- Reason
- May display Calcium results on the screen with wrong arrow direction which may lead to misinterpretation of results and incorrect medical decision. If the unit for iCa++ is set to mg/dL (configured as Service Code MGL) and a measured iCa++ value is lower than the normal range, an upward arrow is shown on the display instead of a downward arrow. The display is set per default to mmol/L; therefore, the arrow indicating an alarm reflects normal ranges of iCa++ in mmol/L. If mg/dL is chosen, the arrow warnings on screen still reflect the ranges from mmol/L, rather than mg/dL. The numeric result is displayed correctly.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1098-2021
- 9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and lithium in the whole blood, serum or plasma, urine, dialysate solutions, or QC materi
Terminated Class II Medical devices
- Recall started
- 17 December 2020
- Terminated
- 19 May 2023
- Reason
- A software error results in the unintentional removal of the serum-indices flag that would otherwise prevent the release of results. The Cobas Inifinity has an auto-verification feature to hold results for manual review when they meet specific criteria. The serum indices flag is used for serum indices tests that are performed to assess the quality of the sample (e.g. hemolysis, icterus, and lipemia). Normally, when the Cobas Infinity receives a result for a test that is serum indices-sensitive, it flags the result and the software then waits for the results of the serum indices tests before validating or rejecting the test result. Roche has discovered a software error that under specific conditions causes the flag to be incorrectly removed. This allows for the possibility that a sample of poor quality may return an unreliable/incorrect test result that is mistakenly reported to the health care provider and/or patient without the proper disclaimer that the result is based on a sample of poor quality.
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0883-2021
- A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data Catalog Number: 07154003001
Ongoing Class II Medical devices
- Recall started
- 8 December 2020
- Reason
- Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several affected parameters. In the case of poor sample quality, discrepant results may remain undetected due to the absence of associated data flags.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0755-2021, Z-0754-2021
- Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units) Chemistry Analyzer (photometric discrete), for clinical use Part Number: 05641446001
- Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 087636
Terminated Class II Medical devices
- Recall started
- 2 December 2020
- Terminated
- 30 June 2022
- Reason
- Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0804-2021, Z-0803-2021
- CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin or warfarin. Catalog 04837738001
- CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. Catalog: 04837975001 Units could consist of any of the
Terminated Class II Medical devices
- Recall started
- 23 November 2020
- Terminated
- 6 July 2023
- Reason
- During the subsequent pipetting (1st or 2nd measurement), the residual reagent can sporadically be transferred from the conus into the reaction cuvette and lead to inaccurately low results for the affected TDMs (Therapeutic Drug Monitoring).
- Distribution
- Domestic: IL, FL, GA, WV
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0752-2021
- cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use
Terminated Class II Medical devices
- Recall started
- 6 November 2020
- Terminated
- 18 October 2024
- Reason
- Roche confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the Tina-quant C-Reactive Protein Gen. 3 on the cobas c701 and 702 modules. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents.
- Distribution
- US Nationwide distribution including in the states of AL, CA, FL, GA, HI, IA, IL, IN, KY, MA, MD, MI, MN, MO, NJ, NY, OH, PA, SC, TN, TX, VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0634-2021
- Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quantitative determination of CRP in human serum and plasma on Roche automated clinical chemistry analyzers.
Terminated Class II Medical devices
- Recall started
- 9 October 2020
- Terminated
- 9 June 2023
- Reason
- Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expiration Control Rule
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0461-2021
- cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be used for the configuration and connectivity management of instruments and software systems Catalog Num
Ongoing Class II Medical devices
- Recall started
- 31 August 2020
- Reason
- Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket, which generates heat, smoke, and eventually burning and melting of the electrical cord connector and socket
- Distribution
- Nationwide Foreign: Canada, Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Tur
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0086-2021, Z-0085-2021
- DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number: 05987750001
- BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001
Terminated Class III Medical devices
- Recall started
- 27 August 2020
- Terminated
- 22 May 2024
- Reason
- Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents.
- Distribution
- Domestic distribution nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0104-2021, Z-0103-2021
- Albumin Gen.2, Catalog 05166861190
- Tina-quant Complement C4 ver.2, Catalog 05991994190
Terminated Class II Medical devices
- Recall started
- 20 August 2020
- Terminated
- 22 October 2021
- Reason
- Recent internal verification studies found the current RF interference claim to no longer be met for the assay on the cobas e 411, 601, and 602 analyzers. Therefore, the claim has been updated.
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2981-2020
- Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190
Terminated Class II Medical devices
- Recall started
- 7 February 2020
- Terminated
- 30 May 2024
- Reason
- The firm has received an increased number of complaints concerning non-reproducible elevated results ("high flyers") for one lot of Elecsys CA 19-9 reagent, which may affect clinical interpretation.
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, CO, FL, HI, IL, IN, KS, KY, MA, ME, MI, NC, NH, NJ, NY, TN, TX, WA and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1444-2020
- Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer
Terminated Class II Medical devices
- Recall started
- 7 January 2020
- Terminated
- 15 October 2020
- Reason
- Alarm flags that have a "<" symbol in front of them are not displayed on the cobas infinity Validation screen. This issue affects only customers that are doing manual validation on the cobas infinity Validation screen.
- Distribution
- Distributed to customers in AK, AL, CA, GA, HI, IA, IL, KY, MA, MI, MN, MO, MS, MT, NJ, NY, OR, SC, and TN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1158-2020
- cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.
Terminated Class II Medical devices
- Recall started
- 28 October 2019
- Terminated
- 28 June 2022
- Reason
- Current software version of the Anti-HAV IgM APP-file (version 06.05-101) downloaded an erroneous Border Area setting, (1.0 1.00) instead of (0.90 1.10).
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0669-2020
- Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma Catalog number: 07026773190
Terminated Class II Medical devices
- Recall started
- 8 October 2019
- Terminated
- 15 October 2020
- Reason
- Cobasinfinity laboratory solution Version 2.4.1 through Version 2.5.4 Using a CommServer Driver - Incorrect Alarm Mapping
- Distribution
- US Nationwide in the states of AL, CA, GA, IA, IL, KY, MI, MO, MT, NJ, NY, OR, TN
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0922-2020
- Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module, For Clinical Use Material Number: 07154003001
Terminated Class II Medical devices
- Recall started
- 4 October 2019
- Terminated
- 9 October 2020
- Reason
- Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules
- Distribution
- US Nationwide distribution in the states of NJ, HI, IA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0679-2020
- Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems Catalog Number: 06542921190 - - Product Usage: The assay can assis
Terminated Class III Medical devices
- Recall started
- 11 September 2019
- Terminated
- 11 June 2024
- Reason
- Due to low Quality Control recovery and invalid Calibration.
- Distribution
- US Nationwide distribution including the states of AL, AZ, CA, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, MI, MO, NE, NH, NJ, NY, OH, OK, PA, PR, RI, SC, TN, TX, UT, VA and WI. Updated as of 12/20/19 to include the following additional US states: CO.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0152-2020, Z-0153-2020
- Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determination of the albumin in human serum and plasma on Roche/Hitachi cobas c systems.
- Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test for the quantitative determination of the total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c syst
Terminated Class II Medical devices
- Recall started
- 28 August 2019
- Terminated
- 2 October 2020
- Reason
- Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0109-2020, Z-0108-2020
- cobas c 701 and 702 Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 05950821190
- cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 20763454122
Terminated Class II Medical devices
- Recall started
- 13 August 2019
- Terminated
- 30 June 2022
- Reason
- AssayTips part of the AssayTip/AssayCup Tray Tips used on the cobas e 801 module- may have an Abnormal Internal Structure and lead to Incorrect patient results
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0044-2020
- AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of analytes in human body fluids) Catalog Number: 5694302001
Terminated Class II Medical devices
- Recall started
- 23 July 2019
- Terminated
- 8 June 2020
- Reason
- Inaccurately Low Sample Results
- Distribution
- AK AL AR AZ CA CO CT DC DE FL GA GU 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 PR RI SC SD TN TX UT VA VT WA WI WV WY
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0042-2020, Z-0043-2020
- Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502
- Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Module: cobas c 311 and cobas c 501/502
Terminated Class II Medical devices
- Recall started
- 18 July 2019
- Terminated
- 15 June 2020
- Reason
- Quality issue with high pressure solenoid valves may cause inaccurate results.
- Distribution
- State NY MT HI IN MD TX OH KS KY CA FL OR LA MO AK
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2476-2019, Z-2478-2019, Z-2477-2019
- cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001
- cobas c513 Analyzer
- Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701 module part Numbers : 05641489001 cobas c 702 module part Numbers : 06473245001
Terminated Class II Medical devices
- Recall started
- 16 July 2019
- Terminated
- 30 April 2021
- Reason
- Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; MODULAR ANALYTICS E 170 module; and cobas e 601, 602, and 801 modules with plasma samples.
- Distribution
- AZ CA FL HI IA IL IN KY LA MA MI MO MT NJ NY OK OR PA PR SC TX VA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2362-2019, Z-2361-2019
- Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160
- Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190
Terminated Class II Medical devices
- Recall started
- 2 July 2019
- Terminated
- 22 October 2021
- Reason
- The firm conducted internal investigations that confirmed customer complaints of quality control (QC) imprecision and calibration failures for the Tina-quant Myoglobin Gen.2 assay (catalog number 04580010190), lot number 349860 on the cobas c311 analyzer and cobas c501 and c502 modules due to a drop in signal in the reaction kinetics. This signal drop was traced to an adjacent cell mixing effect. Sample recovery is decreased as a consequence of the disturbance in reaction kinetics. The investigation found discrepancies of up to -30%. Calibration, QC, and patient samples can be affected. The following issues were reported: - Calibration failures; Dup.E error due to signal drop in reaction kinetics - Sporadic quality control (QC) imprecision. As a long-term solution, the firm will implement required extra wash cycles (EWCs) into the respective Special Wash Requirements method sheets for the cobas c 311 analyzer and cobas c 501 and 502 modules, and into the cobas e-file for the cobas c 502 module. For the use of the reagent with the cobas c501 and c502, Roche will also direct users to run the Tina-Quant Myoglobin gen. 2 assay independently from other tests, in a batch mode status, with a maximum of 39 samples per run. Additionally, a change in the application settings of the Tina-quant Myoglobin Gen.2 assay on the cobas c 501 and 502 modules will be implemented so that adjacent cuvettes are no longer used in order to prevent adjacent cell mixing effects. The application settings change will be communicated at a later date.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2445-2019
- The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay for the quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry analyzers
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.