Device evidence

device-recall:cfres:161800

Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used with Cassette-based immunofluorescent in vitro diagnostic assays . Sofia 2 is intended for professional and laboratory use.

Official recall number

Z-1183-2018

Evidence summary

Product code: PSZ
Recall status: Terminated
Event initiated: December 15, 2017
Root cause: Software Manufacturing/Software Deployment
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-1183-2018