Home / Recalls / Medical Devices
Hyphen BioMed recalls ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitative assay intended for the detection of he
Recalled May 16, 2018 · FDA recall Z-1742-2018 · 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
12
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 MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitative assay intended for the detection of heparin-dependent antibodies of the IgG isotype, in human plasma, by clinical laboratories. It is intended for in vitro diagnostic use.
Manufacturer(s)
Hyphen BioMed
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →