Device Recall ZYMUTEST HIA MonoStrip IgGAM ELISA

Lot numbers: F1600568P1, F1701370P1, F1701370P2

Hematology and Pathology Devices

2

No

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

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