Roche Diagnostics Operations, Inc. Recall 86897
Description: cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use
Roche Diagnostics Operations, Inc. Recall 86897 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0752-2021 |
| Event ID | 86897 |
| Event Description | cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use |
| Product Type | Devices |
| Distribution | Domestic: IL, FL, GA, WV |
| Quantity | 152 kits and 7 units |
| Recall 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). |
| Device Classification | 20210106 |
| Device Code Info | Catalog Number 08445605190 08445567190 08253153190 08058580190 |
| Center Classification Date | 20201229 |
| Recall Initiation Date | 20201123 |
| Recalling Firm | Roche Diagnostics Operations, Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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