FDA-Device2023-12-06Class II
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.
Abbott Molecular, Inc.
Hazard
Abbott has received reports of an increase in reactive negative controls and false positive results in patient samples when using the Identified Lots of Alinity m HCV AMP Kit.
Sold states
Worldwide
Affected count
1,881 units
Manufactured in
1300 E Touhy Ave, Des Plaines, IL, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0407-2024Don't want to check this manually?
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