Roche Diagnostics Operations, Inc.

Complete recall history across all FDA and CPSC categories — 127 total recalls

Roche Diagnostics Operations, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (127)

FDA medical device enforcement actions by Roche Diagnostics Operations, Inc.. Showing most recent 50.

Date Product Reason Class
Jan 20, 2026 cobas pro integrated solutions with cobas c 503 analytical units: cobas pr... Software defect, which allows the system to accept erroneous, non-monotonous ... Class II
Nov 21, 2025 The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay wit... Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-... Class II
Oct 17, 2024 cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, fo... Abnormal calibration signals and control recovery issues on the Homocysteine ... Class II
Aug 15, 2024 Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-I... Creatine Kinase (CK) Assay Abnormal calibrations on the cobas¿ c 311/501/502 ... Class II
Oct 3, 2023 Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay,... Elevated results were detected with Li-heparin plasma samples when compared t... Class II
Dec 12, 2022 cobas infinity central lab, Material Number 07154003001 A complaint investigation revealed that an incorrect behavior relating to the... Class II
Jul 14, 2022 cobas e801 Immunoassay Analyzer Software issue resulting in signals and sample test results of Pre-Wash tests... Class II
Oct 18, 2021 Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 6... A potential risk for false negative nitrite results exists when endogenous cr... Class II
Jun 24, 2021 cobas infinity central lab running software version 3.01.03 through 3.02.08, ... Under specific circumstances created by the user, the cobas e flow test resul... Class II
Apr 26, 2021 IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 031836... Roche received several complaints regarding increased control recovery and di... Class II
Apr 7, 2021 Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intende... Recall reason is possible sporadic false negative conventional troponin resul... Class II
Apr 7, 2021 Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: in... Recall reason is possible sporadic false negative conventional troponin resul... Class II
Jan 6, 2021 9180 Electrolyte Analyzer - Product Usage: intended to be used for the measur... May display Calcium results on the screen with wrong arrow direction which ma... Class II
Dec 17, 2020 A calculator/data processing module for clinical use is an electronic device ... A software error results in the unintentional removal of the serum-indices fl... Class II
Dec 8, 2020 Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas ... Potential for Changed Configuration Settings on the cobas 8000 modular analyz... Class II
Dec 8, 2020 Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e... Potential for Changed Configuration Settings on the cobas 8000 modular analyz... Class II
Dec 2, 2020 CoaguChek XS Prof (Professional) Meters- IVD professional healthcare provider... Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or... Class II
Dec 2, 2020 CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting t... Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or... Class II
Nov 23, 2020 cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric... During the subsequent pipetting (1st or 2nd measurement), the residual reage... Class II
Nov 6, 2020 Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usa... Roche confirmed customer complaints of low quality (QC) recovery and invalid ... Class II
Oct 9, 2020 cobas infinity central lab/cobas infinity core license-The cobas infinity IT ... Potential Incorrect Validation of Results Due to an Erroneous QC Status When ... Class II
Aug 31, 2020 BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001 Potential for Fluid leaks within the instruments, creating an electrical shor... Class II
Aug 31, 2020 DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Nu... Potential for Fluid leaks within the instruments, creating an electrical shor... Class II
Aug 27, 2020 Tina-quant Complement C4 ver.2, Catalog 05991994190 Roche has confirmed customer complaints of low quality (QC) recovery and inva... Class III
Aug 27, 2020 Albumin Gen.2, Catalog 05166861190 Roche has confirmed customer complaints of low quality (QC) recovery and inva... Class III
Aug 20, 2020 Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 063... Recent internal verification studies found the current RF interference claim ... Class II
Feb 7, 2020 Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immu... The firm has received an increased number of complaints concerning non-reprod... Class II
Jan 7, 2020 cobas infinity core, Material No. 7154003001. The device is a calculator/data... Alarm flags that have a "<" symbol in front of them are not displayed on the ... Class II
Oct 28, 2019 Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM anti... Current software version of the Anti-HAV IgM APP-file (version 06.05-101) do... Class II
Oct 8, 2019 Cobas infinity central lab / cobas infinity core license-a Calculator/Data Pr... Cobasinfinity laboratory solution Version 2.4.1 through Version 2.5.4 Using a... Class II
Oct 4, 2019 Roche Homocysteine-In vitro test for the quantitative determination of total ... Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issu... Class II
Sep 11, 2019 Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: I... Due to low Quality Control recovery and invalid Calibration. Class III
Sep 11, 2019 Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - ... Due to low Quality Control recovery and invalid Calibration. Class III
Aug 28, 2019 cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF i... Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rh... Class II
Aug 28, 2019 cobas c 701 and 702 Analyzer/Module-RF interference claims for the sTfR assay... Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rh... Class II
Aug 13, 2019 AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the ... AssayTips part of the AssayTip/AssayCup Tray Tips used on the cobas e 801 m... Class II
Jul 23, 2019 Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Mod... Inaccurately Low Sample Results Class II
Jul 23, 2019 Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Modu... Inaccurately Low Sample Results Class II
Jul 18, 2019 Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 0... Quality issue with high pressure solenoid valves Class II
Jul 18, 2019 cobas c513 Analyzer Quality issue with high pressure solenoid valves Class II
Jul 18, 2019 cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001 Quality issue with high pressure solenoid valves may cause inaccurate results. Class II
Jul 16, 2019 Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190 Performance issues with certain lots of the Elecsys Anti-CCP assay on the cob... Class II
Jul 16, 2019 Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160 Performance issues with certain lots of the Elecsys Anti-CCP assay on the cob... Class II
Jul 2, 2019 The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay... The firm conducted internal investigations that confirmed customer complaints... Class II
Oct 31, 2016 MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: coba... Incorrect Urea results may be generated sporadically on cobas b 221<6>Roche O... Class II
Oct 4, 2016 Tina-Quant Hemoglobin A1c Gen. 2 Hemoglobin A1c test Catalog number 0452812... Roche Diagnostics has confirmed elevated QC and patient sample recovery for i... Class II
Oct 4, 2016 COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test Ca... .Roche Diagnostics has confirmed elevated QC and patient sample recovery for ... Class II
Sep 27, 2016 Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for cl... cobas c 111 analyzers (catalog numbers 04777433001 and 04528778001) with sof... Class II
Jul 15, 2016 cobas 6800/8800 system Hepatitis Viral B DNA Detection Product Usage: Th... Roche has received four reports of injury caused by the sharp edge of the cen... Class II
Jul 15, 2016 cobas p 312 Pre-Analytical System calculator/data processing module, for cli... Roche has received four reports of injury caused by the sharp edge of the cen... Class II

View all 127 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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