Home / Recalls / Medical Devices
Hyphen BioMed recalls ZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770 a qualitative screening assay intended for the global detect
Recalled May 16, 2018 · FDA recall Z-1744-2018 · Hyphen BioMed
Hazard
Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma. · FDA Class II
Units
281
Sold at
OH, MD, NC, NY, NH, Canada, Sweden
Description
Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma.
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.
Manufacturer(s)
Hyphen BioMed
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →