BEUDAMED
    FDA Recall Open, Classified

    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: Z-0407-2024 · Initiated October 30, 2023

    Recall

    Recall Number
    Z-0407-2024
    Event Number
    93230
    Firm
    Abbott Molecular, Inc.
    FEI Number
    3005248192
    Product Code
    MZP
    Status
    Open, Classified
    Root Cause
    Other
    Initiated
    October 30, 2023
    Posted
    November 29, 2023
    Address
    1300 E Touhy Ave, Des Plaines, IL, 60018-3315

    Description

    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.

    Reason

    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.

    Action

    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.

    Distribution

    Worldwide

    Quantity

    1,881 units