medical Class II Updated 2018-05-16

Hyphen BioMed recalls ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 0366353

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Affected States: OH, MD, NC, NY, NH
Lot/Code Info: Lot numbers: F1701084P2 and F1701084P3
View official government recall

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