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Haemonetics Corporation recalls TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
Recalled July 6, 2022 · FDA recall Z-1310-2022 · Haemonetics
Hazard
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. · FDA Class II
Units
3933 kits (US); 2429 kits (OUS)
Sold at
Domestic distribution US Nationwide.
Description
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.
Product
TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
Manufacturer(s)
Haemonetics Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →