Hyphen BioMed recalls ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitative assay intended for the detection of h…

Recall date

February 5, 2018

Source

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

Recall number

Z-1742-2018

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 MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitative assay intended for the detection of heparin-dependent antibodies of the IgG isotype, in human plasma, by clinical laboratories. It is intended for in vitro diagnostic use.