Device evidence

device-recall:cfres:203730

Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for use with the automated Alinity m System to detect and quantitate hepatitis C virus (HCV) RNA in human serum or plasma.

Official recall number

Z-0407-2024

Evidence summary

Product code: MZP
Recall status: Open, Classified
Event initiated: October 30, 2023
Root cause: Other
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-0407-2024