Recall Z-1476-2026 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Roche Diagnostics Operations, Inc.
cobas pro integrated solutions with cobas c 503 analytical 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. L
| Date | Feb 27, 2026 (initiated Jan 20, 2026) |
| Status | Open, Classified |
| Reason | 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 defec |
| Root cause | Software design |
| Action | On 1/20/26, the firm notified affected customers via written Urgent Medical Device Correction letters. Customers were provided with workaround instructions and further instructed to consult with the physician or pathologist at their facility to determine specific clinical implications for patients. This issue has been corrected with the launch of a subsequent cobas pro software version. It is mandatory to upgrade all cobas c 503 analytical units running Spline assays to the latest software version. A Roche Diagnostics Service Representative will contact affected customers to schedule an upgr |
| Quantity | 1261 total |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191899 | Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions Roche Diagnostics, Aug 16, 2019 |