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 test results.
Contact your Roche Diagnostics representative for software update instructions and guidance on managing affected Spline-type assays.
Recall at a glance
- Quantity recalled
- 1261 total
Why it was recalled
Roche Diagnostics is recalling Cobas Pro integrated solutions with Cobas c 503 analytical units due to a software defect that allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. This issue can cause the instrument to repeat the last successfully calculated result for subsequent measurements, leading to identical and incorrect patient and quality control results. This recall is distributed nationwide.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
cobas pro integrated solutions with cobas c 503 analytical
| Product | UDI-DI |
|---|---|
| units: cobas pro sample supply unit, material number 08464502001 cobas pro SSU, material number 09205632001 Affected Assays: (Product Name/ Catalog Number/ Application Code/ Application Short Name) 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 | 07613336158852, 07613336179499 |
| units | – |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification