Device evidence

device-recall:cfres:161801

ZYMUTEST HIA MonoStrip IgGAM. Model Number: RK041D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 32 Tests.

Official recall number

Z-1063-2018

Evidence summary

Product code: LCO
Recall status: Terminated
Event initiated: November 09, 2011
Root cause: Other
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-1063-2018