Device evidence

device-recall:cfres:163462

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.

Official recall number

Z-1742-2018

Evidence summary

Product code: LCO
Recall status: Terminated
Event initiated: February 05, 2018
Root cause: Packaging process control
Source snapshot: d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product: Z-1742-2018