BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported December 6, 2023

    Enforcement

    Recall Number
    Z-0407-2024
    Event ID
    93230
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Abbott Molecular, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 6, 2023
    Initiation Date
    October 30, 2023
    Classification Date
    November 29, 2023
    Address
    1300 E Touhy Ave, Des Plaines, IL, 60018-3315, United States

    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.

    Code Info

    a) 08N50-095: UDI/DI 00884999047648, Lot Numbers: 381582, 382448, 383204; b) 08N50-090: UDI/DI 00884999047761, Lot Numbers: 383203, 385720, 381581, 382447

    Distribution

    Worldwide

    Quantity

    1,881 units