Device evidence

device-recall:cfres:188388

Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories.

Official recall number

Z-2276-2021

Evidence summary

Product code: MZA
Recall status: Open, Classified
Event initiated: July 12, 2021
Root cause: Software design
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-2276-2021