The Recall Desk

Manufacturer

Roche Diagnostics Operations, Inc.

127 recalls in our database name Roche Diagnostics Operations, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
127
Critical
0
Severe
19
Most recent
2026-03-11

Of the 127 recalls from Roche Diagnostics Operations, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 19 (15%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 127

  • HighFDA (Devices)·Z-1476-2026·2026-03-11

    Roche cobas analyzer may repeat previous results for spline calibrated assays

    Roche is recalling cobas pro sample supply units on software versions before 03-02 because a defect can make the analyzer repeat the last calculated result for all later measurements.

    Product
    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 Number/ Application Code/ Application Short Name) 1. Cystati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1009-2026·2026-01-14

    Thyroid receptor immunoassay recalled over variable results across instrument platforms

    Roche Diagnostics is recalling 1,300 Elecsys Anti-TSHR cassettes because results vary by instrument platform and calibrator lots vary, which may lead to incorrect diagnosis or treatment.

    Product
    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 and the reconstituted PT2 containing a pre-formed immunocompl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0489-2025·2024-11-27

    Medical Device Homocysteine Test Assay Recalled for Calibration Defects

    Roche's cobas HCYS homocysteine test assay is recalled due to calibration defects that can produce inaccurate results. The assay can yield false positive or negative values.

    Product
    cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-3187-2024·2024-10-02

    Roche Creatine Kinase test reagents recalled for calibration errors

    Roche Diagnostics is recalling Creatine Kinase test reagents that may exhibit abnormal calibrations, producing inaccurate results. Lot 755471 distributed nationwide.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0352-2024·2023-11-29

    Roche Tina-quant D-Dimer Test System Recalled for Inaccurate Results

    Roche is recalling Tina-quant D-Dimer Test System kits because they produce elevated results when used with lithium-heparin plasma samples, potentially affecting diagnostic accuracy.

    Product
    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)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0952-2023·2023-01-18

    Medical device software bug may cause patient sample order mismatches in rare cases

    A software bug in Roche Diagnostics' cobas infinity central lab may cause orders to be mismatched to wrong patient samples under rare circumstances. The issue affects 224 US units and 2,797 devices worldwide.

    Product
    cobas infinity central lab, Material Number 07154003001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1515-2022·2022-08-17

    Roche cobas e801 Analyzer Recall: Software Defect Affects Test Results

    Roche is recalling approximately 965 cobas e801 Immunoassay Analyzers nationwide due to a software issue that impacts Pre-Wash test signals and results for six diagnostic assays. No injuries or illnesses have been reported.

    Product
    cobas e801 Immunoassay Analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0266-2022·2021-11-24

    Cobas u 601 urinalysis analyzer recalled for false negative nitrite results

    Roche Diagnostics is recalling the Cobas u 601 urinalysis test system due to potential false negative nitrite results when endogenous creatinine levels exceed 15,000 mg/L. The device may fail to detect nitrite in urine samples with elevated creatinine.

    Product
    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 the cobas u pack is a fully automated urinalysis system intend
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2444-2021·2021-09-22

    Roche cobas infinity software may release incorrect test results to laboratories

    Roche Diagnostics is recalling cobas infinity central lab software versions 3.01.03–3.02.08 because under certain circumstances, the software may automatically send false test results to laboratory information systems. Correct results remain available on the instrument.

    Product
    cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1675-2021·2021-06-02

    Roche Recalls Iron Gen 2 Reagent Cassettes Due to Discrepant Results

    Roche Diagnostics is recalling 20,468 Iron Gen 2 reagent cassettes because they may produce discrepant elevated results on specific analyzers.

    Product
    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 Integra systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1596-2021·2021-05-26

    Roche Recalls Troponin I Immunoassay Kits Due to False Negative Risk

    Roche Diagnostics is recalling 726 Elecsys Troponin I Immunoassay kits because they may produce false negative results when run immediately after proBNP II tests on specific modules.

    Product
    Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1595-2021·2021-05-26

    Roche Recalls Troponin I STAT Immunoassay Kits Due to False Negative Risk

    Roche Diagnostics is recalling 10,489 Troponin I STAT Immunoassay kits because they may produce false negative results when run after proBNP II tests on specific modules.

    Product
    Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1098-2021·2021-02-17

    Roche 9180 Electrolyte Analyzer Recalled for Incorrect Calcium Display Arrows

    Roche Diagnostics is recalling 1,214 units of the 9180 Electrolyte Analyzer because the device may display incorrect arrow directions for ionized calcium results when configured in mg/dL, potentially leading to misinterpretation.

    Product
    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 materials. catalog number 03157334001 . in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0883-2021·2021-01-27

    Roche Cobas Infinity Software Error May Allow Unreliable Lab Results

    Roche is recalling 76 licenses of Cobas Infinity software due to an error that may remove quality flags, allowing unreliable test results to be reported.

    Product
    A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data Catalog Number: 07154003001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0804-2021·2021-01-13

    Roche CoaguChek XS PST Meters Recalled for Potential Unit Misinterpretation

    Roche is recalling CoaguChek XS PST meters because they may display blood-clotting results in the wrong units. Users should verify their meter is set to INR.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0803-2021·2021-01-13

    Roche CoaguChek XS Prof Meters Recalled for Potential Unit Misinterpretation

    Roche is recalling CoaguChek XS Prof meters because they may display results in incorrect units, potentially leading to misinterpretation of warfarin monitoring data.

    Product
    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 following strip configurations: 6 count, 24 count, 2x 24 co
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0752-2021·2021-01-06

    Roche cobas c 503 Analyzer Recalled for Inaccurate Test Results

    Roche Diagnostics is recalling cobas c 503 analyzers and kits because residual reagent transfer can cause inaccurately low results for therapeutic drug monitoring tests.

    Product
    cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0754-2021·2021-01-06

    Roche cobas 8000 Modular Analyzer Recall for Potential Configuration Errors

    Roche is recalling cobas 8000 modular analyzers because configuration settings may change, causing incorrect results that could go undetected.

    Product
    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: 08763662001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0755-2021·2021-01-06

    Roche cobas pro integrated solutions recalled for potential incorrect results

    Roche Diagnostics is recalling 7 cobas pro integrated solutions units because configuration settings may cause incorrect clinical results that remain undetected.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0634-2021·2020-12-23

    Roche Recalls Tina-quant C-Reactive Protein Gen.3 Reagents Due to Cross-Contamination

    Roche is recalling Tina-quant C-Reactive Protein Gen.3 reagents due to cross-contamination causing invalid calibrations and low quality control recovery.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0461-2021·2020-11-25

    Roche Recalls cobas infinity Software Due to Incorrect Validation

    Roche Diagnostics is recalling 40 cobas infinity central lab licenses because an erroneous QC status may cause incorrect validation of results.

    Product
    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 Number: 07154003001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0104-2021·2020-10-21

    Roche Recalls Albumin Gen.2 Reagents Due to Cross-Contamination

    Roche Diagnostics is recalling Albumin Gen.2 reagents due to cross-contamination causing low quality recovery and invalid calibrations.

    Product
    Albumin Gen.2, Catalog 05166861190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0103-2021·2020-10-21

    Roche Recalls Tina-quant Complement C4 Reagents Due to Quality Issues

    Roche Diagnostics is recalling 180 units of Tina-quant Complement C4 reagents due to cross-contamination causing invalid calibrations.

    Product
    Tina-quant Complement C4 ver.2, Catalog 05991994190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0085-2021·2020-10-14

    Roche BenchMark ULTRA Advanced Staining System Recalled for Electrical Fire Risk

    Roche Diagnostics is recalling BenchMark ULTRA Advanced Staining Systems due to a risk of fluid leaks causing electrical shorts, heat, and fire.

    Product
    BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0086-2021·2020-10-14

    Roche Discovery Ultra Staining System Recalled for Electrical Short Risk

    Roche Diagnostics is recalling the DISCOVERY ULTRA Advanced Staining System due to fluid leaks that can cause electrical shorts, heat, and smoke.

    Product
    DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number: 05987750001
    Category
    Medical Device
    Distribution
    Distributed nationwide