Cobas Pro Integrated Solutions Analytical Units
Roche is recalling Cobas Pro analytical units due to a software defect that can cause the system to report erroneous, repeated lab results.
Contact your Roche representative to schedule a software update to resolve the calibration defect. In the interim, ensure all Spline-type assay results are verified and do not rely on automated results if calibration errors are suspected.
Why it was recalled
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.
How to identify it
UPC 07613336158852 07613336179499
Where it was sold
Distributed in US.
Official source
Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification