BEUDAMED
    FDA Enforcement Class II Terminated

    NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100

    Recall: Z-1978-2021 · Reported July 7, 2021

    Enforcement

    Recall Number
    Z-1978-2021
    Event ID
    88099
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    NeuMoDx Molecular Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 7, 2021
    Initiation Date
    May 4, 2021
    Classification Date
    June 29, 2021
    Termination Date
    June 21, 2022
    Address
    1250 Eisenhower Pl, N/A, Ann Arbor, MI, 48108-3281, United States

    Description

    NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100

    Reason

    There is a potential for false positive results when certain lots of cartridges are used in conjunction with specific assays.

    Code Info

    GTIN: 10814278020274; Lot Numbers: 106629 106630 106631 106632

    Distribution

    Worldwide distribution.

    Quantity

    620 cases (29,760 cartridges total)