Class II — Roche Diagnostics Operations, Inc.
| Recalling firm | Roche Diagnostics Operations Inc. |
|---|---|
| Registered facility | View this company's 14 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 |
| Product | Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system for clinical chemistry analysis. |
| Quantity | 78 analyzers |
| Distribution | Nationwide Distribution, including the states of AL, AZ, CA, FL, GA, IL, IN, KS, KY, MA, MD, MI, MN, NC, NJ, NY, OH, VA, WA, and WI. |
| Initiated | 2012-11-01 |
| Classified | 2012-12-04 |
| Terminated | 2014-01-08 |
| Recall number | Z-0473-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Roche Diagnostics Operations, Inc. (Z-0473-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63577/
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