Roche Diagnostics Operations, Inc. recalls
Every recall we track for Roche Diagnostics Operations, Inc. — 44 in all, from 2019–2026 — plus the complaints and injury reports the public filed about them. 1 is rated “stop using now”.
Recalls per year, by danger level
Recalls from Roche Diagnostics Operations, Inc. peaked in 2019 (16); 44 since 2017. 2% rated “stop using now”.
All FDA recall records for Roche Diagnostics Operations, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 14 | 2 | 16 |
| 2020 | 1 | 1 | 13 | 0 | 15 |
| 2021 | 0 | 0 | 6 | 0 | 6 |
| 2022 | 0 | 0 | 2 | 0 | 2 |
| 2023 | 0 | 0 | 1 | 0 | 1 |
| 2024 | 0 | 0 | 2 | 0 | 2 |
| 2025 | 0 | 0 | 1 | 0 | 1 |
| 2026 (to date) | 0 | 0 | 1 | 0 | 1 |
Most common reasons for Roche Diagnostics Operations, Inc. recalls
What to do if you have a recalled Roche Diagnostics Operations, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Roche Diagnostics Operations, Inc. recalls
33 shown- Lower riskMedical device
Roche Diagnostics Operations, Inc. recalls cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number
Roche recalls cobas pro integrated solutions with cobas c 503 analytical units due to a software defect that may cause incorrect lab results for specific tests, posing a remote risk of serious health issues.
RocheJan 20, 2026 - Lower riskMedical device
Roche Diagnostics Operations, Inc. recalls The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and
Roche recalls Elecsys Anti-TSHR immunoassay kits due to inconsistent results across instruments and calibrator variations, which may lead to delayed or incorrect thyroid treatment. Affected lots: 08496633190 (exp 02/26), 08496633190 (exp 10/26), 08496609190 (exp 05/26).
RocheNov 21, 2025 - Lower riskMedical device
Roche Diagnostics Operations, Inc. recalls cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test
Roche recalls cobas HCYS Homocysteine Assay (Material REF 06542921190) for potential erroneous patient test results. Affected units sold with cobas c 701/702 devices.
RocheOct 17, 2024 - Lower riskMedical device
Roche Diagnostics Operations, Inc. recalls Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative
Roche recalls CK tests for cobas c 311/501/502 and COBAS INTEGRA 400 plus analyzers due to potential calibration errors causing misdiagnosis. Affected lots expire June 2024.
RocheAug 15, 2024 - Lower riskMedical device
Roche Diagnostics Operations, Inc. recalls Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c
Roche recalls Tina-quant D-Dimer Test System with material numbers 03001245322 and others due to elevated results when using Li-heparin plasma samples. Affected units include specific cobas and Integra models.
RocheOct 3, 2023 - Lower riskMedical device
Roche Diagnostics Operations, Inc. recalls cobas infinity central lab, Material Number 07154003001
Roche recalls specific cobas infinity central lab software versions that may mismatch patient samples due to a configuration error. Affected units must be checked for specific settings.
RocheDec 12, 2022 - Lower riskMedical device
Roche Diagnostics Operations, Inc. recalls cobas e801 Immunoassay Analyzer
Roche recalls cobas e801 Immunoassay Analyzers with software issue causing inaccurate Pre-Wash test results. Affected units have specific serial numbers and catalog numbers. Consumers should contact Roche for details.
RocheJul 14, 2022 - Lower riskMedical device
Roche Diagnostics Operations, Inc. recalls Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 601 urinalysis test system is comprised of
Roche recalls Cobas U 601 urinalysis test systems with potential false negative nitrite results at high creatinine levels. Affected units may require testing adjustments.
RocheOct 18, 2021 - Lower riskMedical device
Roche Diagnostics Operations, Inc. recalls cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
Roche recalls cobas infinity lab software versions 3.01.03 to 3.02.08 due to potential false positive or negative test results in specific user scenarios. Affected systems may need software updates to prevent incorrect lab results.
RocheJun 24, 2021 - Lower riskMedical device
Roche Diagnostics Operations, Inc. recalls IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for
Roche recalls Iron Gen 2 reagent cassettes for inaccurate iron test results on certain analyzers. Affected units may show elevated results or control recovery issues. Consumers should contact Roche for details.
RocheApr 26, 2021 - Lower riskMedical device
Roche Diagnostics Operations, Inc. recalls Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of
Roche recalls Elecsys Troponin I STAT Immunoassay (Catalog# 05094798160) due to possible false negatives in heart attack tests when used with specific analyzers. Affected units may not detect heart attacks correctly.
RocheApr 7, 2021 - Lower riskMedical device
Roche Diagnostics Operations, Inc. recalls 9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of sodium, potassium, chloride,
Roche recalls 9180 Electrolyte Analyzer units with serial numbers listed in the record. The device may display calcium results with incorrect arrow direction, potentially leading to misinterpreted results and incorrect medical decisions.
RocheJan 6, 2021 - Lower riskMedical device
Roche Diagnostics Operations, Inc. recalls A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process
Roche recalls Cobas Infinity calculators for clinical use due to a software error that may remove serum indices flags, risking unreliable test results. Affected units include all versions from cobas infinity 3.00.0:00 onwards.
RocheDec 17, 2020 - Lower riskMedical device
Roche Diagnostics Operations, Inc. recalls Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units) Chemistry Analyzer
Roche recalls specific chemistry analyzers that may produce incorrect test results if configuration settings are changed, affecting clinical testing accuracy.
RocheDec 8, 2020 - Lower riskMedical device
Roche Diagnostics Operations, Inc. recalls CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking
Roche recalls CoaguChek XS PST Meters for possible misinterpretation of blood clotting results, affecting patients using anticoagulants. Ensure your meter displays INR results correctly.
RocheDec 2, 2020 - Lower riskMedical device
Roche Diagnostics Operations, Inc. recalls cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use
Roche recalls cobas c 503 analyzers for inaccurate therapeutic drug monitoring results due to residual reagent transfer during testing. Affected units have specific catalog numbers.
RocheNov 23, 2020 - Lower riskMedical device
Roche Diagnostics Operations, Inc. recalls Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quantitative
Roche recalls Tina-quant C-Reactive Protein Gen 3 (catalog 0517237:42402301) due to low quality recovery and invalid calibrations from cross contamination between reagents.
RocheNov 6, 2020 - Lower riskMedical device
Roche Diagnostics Operations, Inc. recalls cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be
Roche recalls cobas infinity software versions 3.00.00+ for potential incorrect lab results due to QC status errors. Affected units include specific serial numbers listed in the recall notice.
RocheOct 9, 2020 - Stop using nowMedical device
Roche Diagnostics Operations, Inc. recalls DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number: 05987750001
Roche recalls all Discovery Ultra Advanced Staining Systems (RUO) due to potential fluid leaks causing electrical shorts, heat, smoke, and fire. No remedy specified in official notice.
RocheAug 31, 2020 - Lower riskMedical device
Roche Diagnostics Operations, Inc. recalls Albumin Gen.2, Catalog 05166861190
Roche recalls Albumin Gen.2 (Catalog 05166861190) due to yellow discoloration from cross contamination between reagents, causing invalid calibrations and low quality recovery.
RocheAug 27, 2020 - Lower riskMedical device
Roche Diagnostics Operations, Inc. recalls Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190
Roche recalls Elecsys Anti-TPO Assay for cobas e 411/601/602 analyzers due to RF interference claims not meeting standards. All current and upcoming lots affected.
RocheAug 20, 2020 - Lower riskMedical device
Roche Diagnostics Operations, Inc. recalls Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of
Roche recalls specific lots of Elecsys CA 19-9 reagent for possible false high results affecting pancreatic cancer monitoring. Affected lots include 416245 and others listed. No action needed for most users.
RocheFeb 7, 2020 - Lower riskMedical device
Roche Diagnostics Operations, Inc. recalls cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.
Roche recalls cobas infinity core calculator modules for clinical use where alarm flags with < symbol don't display on validation screen. All software versions affected.
RocheJan 7, 2020 - Lower riskMedical device
Roche Diagnostics Operations, Inc. recalls Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM)
Roche recalls Elecsys Anti-HAV IgM assay due to software error causing inaccurate hepatitis A test results. Affected units have specific catalog numbers and software versions.
RocheOct 28, 2019 - Lower riskMedical device
Roche Diagnostics Operations, Inc. recalls Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module, For Clinical Use Material
Roche recalls Cobas Infinity lab software versions 2.4.1 to 2.5.4 due to incorrect alarm mapping that could lead to missed clinical alerts.
RocheOct 8, 2019 - Lower riskMedical device
Roche Diagnostics Operations, Inc. recalls Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum and plasma
Roche recalls homocysteine test kits for cobas c701/702 systems due to calibration failures. Affected lots may give inaccurate results. Contact Roche for details.
RocheOct 4, 2019 - Lower riskMedical device
Roche Diagnostics Operations, Inc. recalls Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the
Roche recalls specific albumin test kits due to potential quality control issues affecting accuracy. Affected lots include 33962301 and 37437: 12/20/19 expansion.
RocheSep 11, 2019 - Lower riskMedical device
Roche Diagnostics Operations, Inc. recalls cobas c 701 and 702 Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 05950821190
Roche recalls cobas c 701 and 702 analyzers due to potential RF interference with sTfR assays. Affected units have catalog number 05950821190 and all serial numbers.
RocheAug 28, 2019 - Lower riskMedical device
Roche Diagnostics Operations, Inc. recalls AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD
Roche recalls AssayTip/AssayCup Trays for cobas e 801 modules due to potential incorrect patient results from abnormal internal structure. Affected units include specific catalog and lot numbers.
RocheAug 13, 2019 - Lower riskMedical device
Roche Diagnostics Operations, Inc. recalls Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502
Roche recalls vancomycin testing devices that may give low sample results. Affected units include cobas c 311 and cobas c 501/502 analyzers with catalog # 06779336190.
RocheJul 23, 2019 - Lower riskMedical device
Roche Diagnostics Operations, Inc. recalls cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001
Roche recalls cobas e 601 modules (part 04745922001) for potential inaccurate test results from a quality issue with high pressure solenoid valves.
RocheJul 18, 2019 - Lower riskMedical device
Roche Diagnostics Operations, Inc. recalls Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160
Roche recalls specific lots of Elecsys Anti-CCP assay kits for performance issues with cobas e 411, e 170, and other analyzers. Affected lots distributed from Feb 2019 to July 2019.
RocheJul 16, 2019 - Lower riskMedical device
Roche Diagnostics Operations, Inc. recalls The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay for the quantitative in vitro
Roche recalls Tina-Quant Myoglobin Gen 2 Tests (lot 349860+) due to calibration failures and QC imprecision from signal drop in reaction kinetics. Affected units may produce inaccurate results.
RocheJul 2, 2019
Roche Diagnostics Operations, Inc. recall questions
How many recalls has Roche Diagnostics Operations, Inc. had?
44 recalls from Roche Diagnostics Operations, Inc. are on record with U.S. safety agencies, from 2019–2026.
What is the most recent Roche Diagnostics Operations, Inc. recall?
Roche Diagnostics Operations, Inc. recalls cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number, dated Jan 20, 2026. Every Roche Diagnostics Operations, Inc. recall is listed on this page, newest first.
Why are Roche Diagnostics Operations, Inc. products recalled?
The most common reasons on record: Due to low Quality Control recovery and invalid Calibration. (2); Inaccurately Low Sample Results (2); Quality issue with high pressure solenoid valves (2).
What should I do if I have a recalled Roche Diagnostics Operations, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Roche Diagnostics Operations, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.