BEUDAMED
    FDA Enforcement Class II Ongoing

    Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096

    Recall: Z-0739-2023 · Reported December 28, 2022

    Enforcement

    Recall Number
    Z-0739-2023
    Event ID
    91202
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Abbott Molecular, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 28, 2022
    Initiation Date
    November 22, 2022
    Classification Date
    December 20, 2022
    Address
    1300 E Touhy Ave, Des Plaines, IL, 60018-3315, United States

    Description

    Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096

    Reason

    Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.

    Code Info

    Lot Numbers: 381465, exp 8/24/2023; 524433, exp 1/5/2023; 526710, exp 1/21/2023; 527845, exp 2/8/20231499

    Distribution

    Worldwide

    Quantity

    3896 kits