medical Class II Updated 2018-05-16

Hyphen BioMed recalls ZYMUTEST HIA MonoStria qualitative screening assay intended

Recalled Product

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

Hazard / Issue

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

Issued by

FDA

Affected States: OH, MD, NC, NY, NH
Lot/Code Info: Lot numbers: F1600568P1, F1701370P1, F1701370P2
View official government recall

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