Hyphen BioMed recalls ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of heparin-dependent antibodies, w…

Recall date

February 5, 2018

Source

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

Recall number

Z-1743-2018

FDA classification

Class II

Brand / firm

Hyphen BioMed

Sold / distributed

OH, MD, NC, NY, NH, Canada, Sweden

Why it was recalled

Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma.

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

What was recalled

ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of heparin-dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratories. p IgGAM; REF Number: RK041D; UDI: 03663537046810