Biomerieux Inc Recall 91148
Description: VITEK 2 REAGENT AST-N801 TEST KIT 20 CARDS, CATALOG 423416
Biomerieux Inc Recall 91148 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0856-2023 |
| Event ID | 91148 |
| Event Description | VITEK 2 REAGENT AST-N801 TEST KIT 20 CARDS, CATALOG 423416 |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 64 units |
| Recall Reason | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Device Classification | 20230111 |
| Device Code Info | UDI/DI 03573026618834, Batch Numbers: 412148504 |
| Center Classification Date | 20230104 |
| Recall Initiation Date | 20221109 |
| Recalling Firm | Biomerieux Inc |
| Initial Notification | |
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