FDA Device recall Z-0752-2021
cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use
- FDA Device
- Class II
- terminated
- Published 2021-01-06
On 2021-01-06 the FDA classified a Class II recall of cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use by Roche Diagnostics Operations, citing 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 lo….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0752-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-11-23 |
| Published | 2021-01-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Roche Diagnostics Operations |
| Distribution | FL, GA, IL, WV |
Product
cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use
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).
Identifiers
| code_info | Catalog Number 08445605190 08445567190 08253153190 08058580190 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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All Roche Diagnostics Operations recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0752-2021%22
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