Haemonetics Corporation Recall 90323
Description: TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
Haemonetics Corporation Recall 90323 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1310-2022 |
| Event ID | 90323 |
| Event Description | TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034 |
| Product Type | Devices |
| Distribution | Domestic distribution US Nationwide. |
| Quantity | 3933 kits (US); 2429 kits (OUS) |
| Recall Reason | Due to a shift in the citrated blood reference range for a normal population, the ranges stated in the IFU are changing. If the clinician relies solely on affected results in comparison to the normal donor reference range, it could lead to misdiagnosis and incorrect treatment or failure to treat. |
| Device Classification | 20220706 |
| Device Code Info | UDI-DI: (01)20812747018095 All lots are affected. |
| Center Classification Date | 20220630 |
| Recall Initiation Date | 20220426 |
| Recalling Firm | Haemonetics Corporation |
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