Device evidence

device-recall:cfres:200547

Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac disease Material Number 12410002

Official recall number

Z-2041-2023

Evidence summary

Product code: MST
Recall status: Open, Classified
Event initiated: May 01, 2023
Root cause: Under Investigation by firm
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-2041-2023