Device evidence

device-recall:cfres:171330

VITROS¿ ECi/ECiQ Immunodiagnostic System Product Code: 1922814 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents

Official recall number

Z-1292-2019

Evidence summary

Product code: KHO
Recall status: Terminated
Event initiated: February 20, 2019
Root cause: Software design
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-1292-2019