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 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.

Abbott issued an Urgent Field Safety Notice to its consignees on 10/30/2023 via letter delivered using FedEx priority overnight express. The notice explained the problem, the potential impact/risk to patient, and requested the following actions: -discard all affected product -notify all those to which the products were transferred -follow internal laboratory procedures in the case of suspected incorrect results Credit or replacement will be issued for units discarded/destroyed. Abbott expanded the recall and notified consignees on 07/23/2024 via letter. The letter instructed consignees of an additional lot number included in the recall, but otherwise contained the same instructions.