cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502
FDA device recall Z-1476-2026 · posted 2026-02-27 · Open, Classified
Recall details
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Reason for recall
- 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.
- Action taken
- 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 upgrade to software version 03-03.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- JJE
- Quantity affected
- 1261 total
- Distribution
- US Nationwide distribution.
- Date initiated
- 2026-01-20
- Date posted
- 2026-02-27
- Location
- Indianapolis, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions (K191899) | Roche Diagnostics | 2019-08-16 |