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.

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

Code information: Lot numbers: F1600568P1, F1600568P2, F1700415P1, F1700415P2, F1701369P1, F1701369P2

Distribution pattern: OH, MD, NC, NY, NH, Canada, Sweden