FDA recall, , Moderate risk
Cobas Pro Integrated Solutions with Cobas C 503 analytical Units
The cobas pro integrated solutions with cobas c 503 analytical units have a software defect that can cause erroneous patient results.
Summary by Recall Canary from the FDA notice
What happened
Roche Diagnostics Operations, Inc., of Indianapolis, Indiana, is recalling the cobas pro integrated solutions with cobas c 503 analytical units because a software defect allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. The affected assays include Cystatin C Gen.2, Ferritin Gen.4, Lipoprotein (a) Gen.2, Lipoprotein (a) molarity, and Vancomycin Gen.3.
The product is an automated analyzer intended for qualitative, semi-quantitative and quantitative clinical chemistry and immunochemistry assays, as well as ion-selective measurements.
The recall began January 20, 2026, and was added to the FDA's Enforcement Report on February 27, 2026, with US Nationwide distribution.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
cobas pro integrated solutions with cobas c 503 analytical units
- UDI-DI
- 07613336158852
- 07613336179499
Recall details
- Company began the recall
- Sold in
US Nationwide distribution.
- Company
- Roche Diagnostics Operations, Inc.Indianapolis, Indiana
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98347
- Recall number
- Z-1476-2026
- Quantity recalled
- 1261 total
All recalls from Roche Diagnostics Operations, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
