cobas pro integrated solutions -cobas c 503 — Class II medical device recall Z-0752-2021
Terminated recall by Roche Diagnostics Operations, Inc., reported 2021-01-06, distributed in FL, GA, IL, WV. During the subsequent pipetting (1st or 2nd measurement), the residual reagent can sporadically be transferred
| Recall number | Z-0752-2021 |
|---|---|
| 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 | 2020-11-23 |
| Classified | 2020-12-29 |
| Reported by FDA | 2021-01-06 |
| Terminated | 2023-07-06 |
| Distributed | FL, GA, IL, WV |
| Model numbers | 08058580190, 08253153190, 08445567190, 08445605190 |
Product
cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use
Reason for recall
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).
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-0752-2021. 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.