Hyphen BioMed recalls ZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770
Recalled Product
ZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770 a 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.
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
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