Roche Diagnostics Operations, Inc.: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Updated 2 hours ago ()
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.
- Tags
- FDA recall, medical device, class 1, Clinical Chemistry, Software design, Open, Classified
- Related exam domains
- CISSP 3: Security Architecture and Engineering; CISSP 8: Software Development Security; CISM 2: Information Security Risk Management
- Source record id
- Z-1476-2026
- First seen by InfoSec Signals
- Sep 23, 2026
Source: openFDA device recalls, U.S. Food and Drug Administration about this source more from it
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