Roche Diagnostics issued a nationwide recall of 1,261 Cobas Pro systems with cobas c 503 units in the United States. A software defect can cause erroneous, non-monotonic calibrations for spline-type assays. Labs should stop using the devices immediately and follow the manufacturer's recall instructions.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Roche Diagnostics Operations, Inc. or your healthcare provider for instructions. Notification method: Letter
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The cobas pro integrated solutions system, including cobas c 503 units, is an automated analyzer used in clinical laboratories to run qualitative, semi-quantitative and quantitative chemistry and immunochemistry assays.
A software fault can cause the system to repeat the last valid result for spline-type assays. This can produce identical, incorrect patient and QC results, potentially affecting patient care.
This recall is not stated as part of a broader industry pattern.
Labs may produce inaccurate results. This can affect diagnosis and treatment plans and may require retesting and clinical review.
Recall letter from Roche Diagnostics Operations, FDA enforcement page, and Roche’s official recall notices.
Timeline for resolution not provided by the manufacturer. Follow recall instructions for updates.
Preserve the recall letter, maintain a log of communications with the manufacturer, and document any test results affected by the defect.
Product: cobas pro integrated solutions with cobas c 503 analytical units. Cobas pro sample supply unit material number 08464502001. Cobas pro SSU material number 09205632001. Assays affected 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. Distribution: US Nationwide. Quantity: 1261 total units. Recall date: 2026-01-20. Manufacturer: Roche Diagnostics Operations.
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