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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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.
A software defect allows the cobas pro system to accept erroneous calibrations for spline-type assays. The instrument then repeats the last valid result for all subsequent measurements. This yields identical and erroneous patient and quality control results. The defect could lead to incorrect lab results with a remote risk of serious adverse health consequences.
1. Stop using the device immediately. 2. Identify affected units by model numbers and material numbers listed above. 3. Follow the recall instructions provided by Roche Diagnostics Operations, Inc. 4. Notify your healthcare facility leadership and laboratory supervisor. 5. Contact Roche Diagnostics Operations, Inc. for instructions and monitor for recall updates.
Recall notifications are issued by letter. For instructions, contact Roche Diagnostics Operations, Inc. or your healthcare provider. Refer to the official FDA enforcement notice for details.
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