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FDAOctober 30, 2023device

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 recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

abbott molecularabbott

UPCs

0088499904764800884999047761

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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. — Recall Details · AllClear