FDA-Device2022-07-06Class II
TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
Haemonetics Corporation
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.
Sold states
Domestic distribution US Nationwide.
Affected count
3933 kits (US); 2429 kits (OUS)
Manufactured in
125 Summer St, Boston, MA, United States
Products
TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1310-2022Don't want to check this manually?
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