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 | During the subsequent pipetting (1st or 2nd measurement), the residual reagent can sporadically be transferred from the conus into the reaction cuvette and lead to inaccurately low results for the affected TDMs (Therapeutic Drug Monitoring). |
| Product | cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use |
| Quantity | 152 kits and 7 units |
| Distribution | Domestic: IL, FL, GA, WV |
| Initiated | 2020-11-23 |
| Classified | 2020-12-29 |
| Terminated | 2023-07-06 |
| Recall number | Z-0752-2021 |
| 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-0752-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86897/
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