ORTHO-CLINICAL DIAGNOSTICS Recall 92662
Description: VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
ORTHO-CLINICAL DIAGNOSTICS Recall 92662 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2357-2023 |
| Event ID | 92662 |
| Event Description | VITROS Immunodiagnostic Products Troponin I ES Reagent Pack |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| Quantity | 4,013 units |
| Recall Reason | Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results. |
| Device Classification | 20230816 |
| Device Code Info | Product Code: 6802301; UDI-DI: 10758750002504; Lot No.: 4800; Expiration Date: 10-Jun-2023. |
| Center Classification Date | 20230808 |
| Recall Initiation Date | 20230605 |
| Recalling Firm | ORTHO-CLINICAL DIAGNOSTICS |
| Initial Notification | Letter |
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