Reported Mar 11, 2026 · Ongoing
cobas pro integrated solutions with cobas c 503 analytical units
Roche Diagnostics Operations, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Roche Diagnostics Operations, Inc. · 9115 Hague Rd · Indianapolis, IN · 46256-1025
Is this the product you have?
cobas pro integrated solutions with cobas c 503 analytical units
8 of 8 products
| # | Product as published |
|---|---|
| 1 | Cystatin C Gen.2 08105596190 20510 CYSC2 |
| 2 | Ferritin Gen.4 08057648190 20571 FER4X |
| 3 | Lipoprotein (a) Gen.2 08106126190 20861 LPA2X |
| 4 | Lipoprotein (a) molarity 08106126160 20864 LPA2-X |
| 5 | Vancomycin Gen.3 08058849190 21211 VANC3O |
| 6 | Kappa Free Light Chains Partner Channel 08896640190 21421 KFLCX |
| 7 | Lambda Free Light Chains Partner Channel 08896631190 21430 LFLC |
| 8 | fCAL turbo Partner Channel 08910367190 21490 FCAL |
- Lot codes and dates
- cobas pro sample supply unit, UDI-DI 07613336158852 cobas pro SSU, UDI-DI 07613336179499 all software versions previous to 03-02
- Amount recalled
- 1261 total
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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