Lower risk Medical device recall · FDA · Published January 20, 2026

Roche cobas pro integrated solutions recall: Software defect causes incorrect lab results

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1476-2026Medical device Roche ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmRoche Diagnostics Operations, Inc.9115 Hague Rd · Indianapolis, IN 46256-1025

✎ GovInfoNow plain-language explainer

Roche is recalling cobas pro integrated solutions with cobas c 503 analytical units because a software defect can cause the system to accept incorrect calibrations for certain tests. This may lead to patients receiving inaccurate lab results, which could result in serious health consequences if not addressed. Read more at govinfonow.com/recall/50135-roche-cobas-pro-integrated-solutions-recall-software-defect-causes-incorrect.

Source Summary by GovInfoNow · govinfonow.com/recall/50135-roche-cobas-pro-integrated-solutions-recall-software-defect-causes-incorrect · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1476-2026

Cite this page

“Roche cobas pro integrated solutions recall: Software defect causes incorrect lab results.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50135-roche-cobas-pro-integrated-solutions-recall-software-defect-causes-incorrect. Based on FDA recall #Z-1476-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1476-2026%22&limit=1).

The FDA announced on Jan. 20, 2026, that Roche Diagnostics Operations Inc. is recalling cobas pro integrated solutions with cobas c 503 analytical units due to a software defect. The hazard involves the system accepting erroneous calibrations for specific Spline-type assays, potentially leading to identical and incorrect patient results.

How to tell if you have it

Brand: Roche
Product: cobas pro integrated solutions with cobas c 503 analytical units
Material numbers: 08464502001, 09205632001
UDI-DI codes: 07613336158852, 07613336179499
Affected assays: Cystatin C Gen.2 (08105596190), Ferritin Gen.4 (08057648190), Lipoprotein (a) Gen.2 (08106126190), Lipoprotein (a) molarity (08106126160), Vancomycin Gen.3 (08058849190), Kappa Free Light Chains Partner Channel (08896640190), Lambda Free Light Chains Partner Channel (08896631190), fCAL turbo Partner Channel (08910367190)
Software versions: previous to 03-02
Distribution: US Nationwide
Units affected: 1261

The hazard

GovInfoNow's records show the software defect allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. When active, the instrument fails to calculate new values and repeats the last successfully calculated result for all subsequent measurements, leading to identical and erroneous patient and QC results. This could result in a remote risk of serious adverse health consequences.

Context

GovInfoNow's records show Roche Diagnostics Operations Inc. has 32 other recalls on record since 2019-07-02. Other recent recalls of similar products include Roche Elecsys Anti-TSHR Assay Recall (2025-11-21), Roche cobas HCYS Assay Recall (2024-10-17), and Roche CK Test Recalls (2024-08-15). Other recent recalls of similar products include Baxter Novum IQ Syringe Pump Recall (2026-08-11), Beckman Coulter Access Total T4 Calibrator Recall (2026-03-16), and DASH Rapid PCR Instrument Software Issue Recall (2025-10-22).

How to tell if you have this one

Check if your device has cobas pro sample supply unit with material number 08464502001 or cobas pro SSU with material number 09205632001. The affected assays include specific tests like Cystatin C Gen.2, Ferritin Gen.4, and others listed in the recall.

Brand
Roche
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Model
Identify if your device has cobas pro sample supply unit with material number 08464502001 or cobas pro SSU with material number 09205632001.
Contact Roche
Reach out to Roche Diagnostics Operations, Inc. for further assistance with the recall.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 50 days after the firm started it.

Jan 20, 2026Firm started the recall
Feb 27, 2026FDA classified it Class II
Mar 11, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/50135-roche-cobas-pro-integrated-solutions-recall-software-defect-causes-incorrect">Roche cobas pro integrated solutions recall: Software defect causes incorrect lab results (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1476-2026 (January 20, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1476-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.