Roche Diagnostics Recalls cobas pro Integrated Solutions Due to Software Defect
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Roche Diagnostics is recalling 1,261 units of cobas pro integrated solutions because a software defect may cause erroneous patient lab results for multiple assays.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 2, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.
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What Happened
Roche Diagnostics Operations, Inc. has initiated a voluntary recall for its cobas pro integrated solutions with cobas c 503 analytical units. The recall is due to a software defect that allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. When an erroneous calibration is active, the instrument fails to calculate new values and instead repeats the last successfully calculated result for all subsequent measurements. This leads to identical and erroneous patient and quality control (QC) results.
Which Products Are Affected
The recall affects 1,261 units distributed nationwide across the United States. Affected products include:
- cobas pro sample supply unit: Material number 08464502001 (UDI-DI 07613336158852)
- cobas pro SSU: Material number 09205632001 (UDI-DI 07613336179499)
- Software Versions: All versions prior to 03-02.
The following assays use spline-type calibration and are affected by this issue:
- Cystatin C Gen.2 (Catalog 08105596190)
- Ferritin Gen.4 (Catalog 08057648190)
- Lipoprotein (a) Gen.2 (Catalog 08106126190)
- Lipoprotein (a) molarity (Catalog 08106126160)
- Vancomycin Gen.3 (Catalog 08058849190)
- Kappa Free Light Chains Partner Channel (Catalog 08896640190)
- Lambda Free Light Chains Partner Channel (Catalog 08896631190)
- fCAL turbo Partner Channel (Catalog 08910367190)
What You Should Do
Roche Diagnostics notified customers of the issue via a formal letter initiated on January 20, 2026. Laboratories using the affected cobas pro systems should ensure they update their software to version 03-02 or later. For further assistance or questions regarding the recall, customers can contact Roche Diagnostics Operations, Inc. at 9115 Hague Rd, Indianapolis, IN 46256.
Why This Matters
This software defect could lead to patients receiving erroneous laboratory results. Inaccurate medical data poses a risk of serious adverse health consequences, as clinical decisions and treatments may be based on incorrect diagnostic information.
Source
Information provided by the U.S. Food and Drug Administration (FDA) under recall number Z-1476-2026.
Original source: FDA Official Notice ↗
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