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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:189113

Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

Official recall number

Z-0004-2022

Evidence summary

Product code
QJR
Recall status
Terminated
Event initiated
September 02, 2021
Root cause
Device Design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0004-2022