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.
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.
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.
The software defect allows the system to accept erroneous calibrations for Spline-type assays. When this happens, the instrument repeats the last correct result instead of calculating new values, leading to identical and incorrect patient and quality control results for affected tests.
Patients using Roche cobas pro integrated solutions with cobas c 503 analytical units for clinical testing are affected. Those running specific assays listed in the recall are most at risk of receiving incorrect lab results.
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.
Identify if your device has cobas pro sample supply unit with material number 08464502001 or cobas pro SSU with material number 09205632001.
Reach out to Roche Diagnostics Operations, Inc. for further assistance with the recall.
The affected tests include 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.
Check if your device has cobas pro sample supply unit with material number 08464502001 or cobas pro SSU with material number 09205632001.
Contact Roche Diagnostics Operations, Inc. for further assistance with the recall.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-1476-2026 — Roche Roche Hello, I own a Roche that is covered by recall Z-1476-2026 from Roche. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
