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.

26–50 of 127

  • ModerateFDA (Devices)·Z-2981-2020·2020-09-23

    Roche Recalls Anti-TPO Assay Kits Due to Updated Interference Claim

    Roche Diagnostics is recalling 11,870 Elecsys Anti-TPO Assay kits because internal studies found the radio frequency interference claim no longer met for specific cobas e analyzers.

    Product
    Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1444-2020·2020-03-11

    Roche Recalls Elecsys CA 19-9 Reagent Due to Non-Reproducible Results

    Roche Diagnostics is recalling 684 units of Elecsys CA 19-9 reagent because non-reproducible elevated results may affect clinical interpretation.

    Product
    Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1158-2020·2020-02-19

    Roche Recalls cobas infinity core Software Due to Display Error

    Roche Diagnostics is recalling cobas infinity core software modules because alarm flags with a '<' symbol are not displayed on the Validation screen.

    Product
    cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-0922-2020·2020-02-05

    Roche Cobas infinity Software Recalled for Incorrect Alarm Mapping

    Roche Diagnostics is recalling 20 Cobas infinity software modules due to incorrect alarm mapping. The software versions 2.4.1 through 2.5.4 are affected.

    Product
    Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module, For Clinical Use Material Number: 07154003001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0679-2020·2019-12-25

    Roche Homocysteine Test Recalled for Calibration Failures and Quality Control Issues

    Roche Diagnostics is recalling 82 units of Homocysteine tests due to calibration failures and quality control recovery issues on cobas c 701 and 702 modules.

    Product
    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 assist in the diagnosis of patients suspected of having hyperhomo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0669-2020·2019-12-18

    Roche Recalls Anti-HAV IgM Assay Due to Software Error

    Roche Diagnostics is recalling 712 units of the Elecsys Anti-HAV IgM assay because a software error caused incorrect test settings to be downloaded.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0153-2020·2019-10-23

    Roche Cobas c Bilirubin Total Gen.3 Recalled for Quality Control Issues

    Roche Diagnostics is recalling 2,304 units of the Cobas c Bilirubin Total Gen.3 in vitro test due to low quality control recovery and invalid calibration.

    Product
    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 systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0152-2020·2019-10-23

    Roche Diagnostics Recalls cobas Integra Albumin Gen.2 Test Kits

    Roche Diagnostics is recalling cobas Integra Albumin Gen.2 test kits due to low quality control recovery and invalid calibration.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0108-2020·2019-10-16

    Roche Tina-quant sTfR Assay Recalled for Rheumatoid Factor Interference

    Roche Diagnostics is recalling Tina-quant sTfR assays due to updated claims regarding rheumatoid factor interference.

    Product
    cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 20763454122
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0043-2020·2019-10-16

    Roche Online TDM Vancomycin Gen.3 Recalled for Inaccurate Low Sample Results

    Roche Diagnostics is recalling Online TDM Vancomycin Gen.3 kits because they may produce inaccurately low sample results.

    Product
    Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Module: cobas c 311 and cobas c 501/502
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-0042-2020·2019-10-16

    Roche Vancomycin Test Recall Due to Inaccurate Low Results

    Roche Diagnostics is recalling Online TDM Vancomycin Gen.3 tests because they may produce inaccurately low sample results.

    Product
    Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-0044-2020·2019-10-16

    Roche AssayTip/AssayCup Tray Recall for Abnormal Internal Structure

    Roche Diagnostics is recalling AssayTip/AssayCup Trays used on the cobas e 801 module due to abnormal internal structure that may lead to incorrect patient results.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0109-2020·2019-10-16

    Roche Tina-quant sTfR Assay Recalled for Rheumatoid Factor Interference

    Roche Diagnostics is recalling Tina-quant Soluble Transferrin Receptor (sTfR) assays due to updated claims regarding rheumatoid factor interference.

    Product
    cobas c 701 and 702 Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 05950821190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2477-2019·2019-09-11

    Roche Recalls Cobas 8000 Analyzer Modules Due to Valve Quality Issue

    Roche Diagnostics is recalling 19 Cobas 8000 Modular Analyzer Series units due to a quality issue with high pressure solenoid valves.

    Product
    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
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-2476-2019·2019-09-11

    Roche cobas e 601 Module Recalled for Inaccurate Results

    Roche Diagnostics is recalling cobas e 601 modules due to a quality issue with high pressure solenoid valves that may cause inaccurate test results.

    Product
    cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-2445-2019·2019-09-11

    Roche Tina-Quant Myoglobin Gen. 2 Assay Recalled for QC Imprecision

    Roche is recalling Tina-Quant Myoglobin Gen. 2 assays due to signal drops causing calibration failures and QC imprecision on specific analyzers.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2361-2019·2019-09-04

    Roche Elecsys Anti-CCP Immunoassay Recalled Due to Performance Issues

    Roche Diagnostics is recalling specific lots of the Elecsys Anti-CCP Immunoassay due to performance issues when used with plasma samples on certain analyzers.

    Product
    Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190
    Category
    Medical Device
    Distribution
    22 states
  • ModerateFDA (Devices)·Z-2362-2019·2019-09-04

    Roche Elecsys Anti-CCP Immunoassay Recalled for Performance Issues

    Roche Diagnostics is recalling specific lots of the Elecsys Anti-CCP Immunoassay due to performance issues when used with plasma samples on certain analyzers.

    Product
    Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Devices)·Z-1092-2017·2017-02-01

    Roche Tina-Quant CRP Latex Test System Recalled for Low Results

    Roche is recalling Tina-Quant CRP Latex High Sensitive test kits due to potential under-recovery of results, which may lead to incorrect cardiovascular risk assessments.

    Product
    Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) The Tina-Quant CRP (Latex) High Sensitive Immunoturbidimetric assay is for the in-vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma on Roche automated clinical che
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1077-2017·2017-02-01

    Roche Recalls 30 Cobas b 123 POC Systems for Quality Control Issue

    Roche Diagnostics is recalling 30 cobas b 123 POC systems because a software issue may prevent automatic quality control from running, potentially leading to undetected incorrect test results.

    Product
    Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes Nat, K+, iCaWt (ISE), hematocrit (THct), metabolites (Glu, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0673-2017·2016-12-07

    Roche OMNI S Cassette Recall for Incorrect Urea Measurement Results

    Roche is recalling 97 MSS Cassette units for the OMNI S Analyzer due to a software error that may cause incorrect urea results, potentially delaying diagnosis of inborn disorders in children.

    Product
    MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6 system The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0395-2017·2016-11-23

    Roche Tina-Quant Hemoglobin A1c Test Recalled for Erroneously High Results

    Roche Diagnostics is recalling Tina-Quant Hemoglobin A1c Gen. 2 tests because they may produce erroneously high results, potentially leading to incorrect diabetes treatment.

    Product
    Tina-Quant Hemoglobin A1c Gen. 2 Hemoglobin A1c test Catalog number 04528123190 / 05401640190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0396-2017·2016-11-23

    Roche Recalls Hemoglobin A1c Test Cassettes Due to High Results

    Roche Diagnostics is recalling specific Hemoglobin A1c test cassettes because they may produce erroneously high results.

    Product
    COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test Catalog number 04528123160
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0387-2017·2016-11-16

    Roche COBAS INTEGRA c111 Analyzer Recall for Software Error

    Roche is recalling 139 COBAS INTEGRA c111 analyzers due to a software error that may cause erroneous test results.

    Product
    Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use Product Usage: The Roche COBAS INTEGRA c111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measu
    Category
    Medical Device
    Distribution
    Distributed nationwide