Hyphen BioMed Recalls
5 recalls on record · March 21, 2018 to May 16, 2018 · Medical Devices
May 16, 2018Medical DevicesFDA
Hyphen BioMed recalls ZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770 a qualitative screening assay intended for the global detect
Hazard: Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma.
May 16, 2018Medical DevicesFDA
Hyphen BioMed recalls ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of heparin-dependent antibodies, wh
Hazard: Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma.
May 16, 2018Medical DevicesFDA
Hyphen BioMed recalls ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitative assay intended for the detection of he
Hazard: Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma.
March 21, 2018Medical DevicesFDA
Hyphen BioMed recalls ZYMUTEST HIA MonoStrip IgGAM. Model Number: RK041D. Qualitative screening assay for the detection of heparin-dependent
Hazard: A voluntary recall is initiated for ZYMUTEST HIA lgGAM - Ref RK040D - Lot F1700415 and ZYMUTEST HIA MonoStrip lgGAM - Ref RK041D - Lot F1700416 because they may produce false positive results.
March 21, 2018Medical DevicesFDA
Hyphen BioMed recalls ZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for the detection of heparin-dependent antibodi
Hazard: A voluntary recall is initiated for ZYMUTEST HIA lgGAM - Ref RK040D - Lot F1700415 and ZYMUTEST HIA MonoStrip lgGAM - Ref RK041D - Lot F1700416 because they may produce false positive results.