Cobas 8000 Modular Analyzer Series — Class II medical device recall Z-0473-2013
Terminated recall by Roche Diagnostics Operations, Inc., reported 2012-12-12, distributed nationwide. On cobas c 701 and cobas c 702 modules of the Cobas 8000 series analyzer, a mismatch between the reagent probe
| Recall number | Z-0473-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Operations, Inc., Indianapolis, IN, United States |
| Recall initiated | 2012-11-01 |
| Classified | 2012-12-04 |
| Reported by FDA | 2012-12-12 |
| Terminated | 2014-01-08 |
| Distributed | Nationwide (US) |
| Quantity | 78 analyzers |
| Serial numbers | 0917-10, 1020-04, 1020-05, 1021-03, 1021-04, 1021-07, 1021-08, 1023-06, 1023-09, 1023-10, 1024-03, 1024-04, 1024-05, 1024-09, 1025-02, 1025-05, 1025-07, 1025-09, 1026-01, 1026-02, 1027-09, 1028-01, 1028-07, 1030-09, 1031-05 and 53 more |
| Model numbers | 05641489001 |
Product
Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system for clinical chemistry analysis.
Reason for recall
On cobas c 701 and cobas c 702 modules of the Cobas 8000 series analyzer, a mismatch between the reagent probe positioning and the aspirated reagent volumes under certain conditions can lead to insufficient reagent pipetting. This may affect patient sample and controls recovery for the following tests: Alkaline Phosphatase (ALP2), Alanine Aminotransferase (ALT), Bicarbonate (CO2-L), Creatinine (C
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0473-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.