Z-1310-2022 Class II Terminated
FDA device recall Z-1310-2022 was initiated by Haemonetics Corporation on April 26, 2022 and is designated Class II. Reason for recall: 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 … The recall status is terminated (terminated March 15, 2024). Affected quantity: 3933 kits (US); 2429 kits (OUS).
Recall Details
- Product Type
- Devices
- Report Date
- July 6, 2022
- Initiation Date
- April 26, 2022
- Termination Date
- March 15, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3933 kits (US); 2429 kits (OUS)
Product Description
TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
Reason for Recall
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.
Distribution Pattern
Domestic distribution US Nationwide.
Code Information
UDI-DI: (01)20812747018095 All lots are affected.