Haemonetics Corporation recalls TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034

Recall date

April 26, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1310-2022

FDA classification

Class II

Brand / firm

Haemonetics Corporation

Sold / distributed

Domestic distribution US Nationwide.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034