Abbott Laboratories Recall 90692
Description: ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
Abbott Laboratories Recall 90692 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1660-2022 |
| Event ID | 90692 |
| Event Description | ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27 |
| Product Type | Devices |
| Distribution | Nationwide |
| Quantity | 2451 kits of 100 tests |
| Recall Reason | One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component. |
| Device Classification | 20220907 |
| Device Code Info | UDI (01) 00380740048525 (17) 991231 (10) 12345M100 (240) 2K4127 Lot lot 63718UN22 |
| Center Classification Date | 20220830 |
| Recall Initiation Date | 20220726 |
| Recalling Firm | Abbott Laboratories |
| Initial Notification | Letter |
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