BEUDAMED
    FDA Enforcement Class II Ongoing

    NxTAG Respiratory Pathogen Panel, REF: I051C0447

    Recall: Z-0042-2025 · Reported October 16, 2024

    Enforcement

    Recall Number
    Z-0042-2025
    Event ID
    95377
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Luminex Molecular Diagnostics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 16, 2024
    Initiation Date
    September 5, 2024
    Classification Date
    October 9, 2024
    Address
    439 University Ave Suite 900, Toronto, N/A, Canada

    Description

    NxTAG Respiratory Pathogen Panel, REF: I051C0447

    Reason

    Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus) results, risk identified predominantly in clinical samples that present positivity for another target, leading to an erroneous co-infection result, can potentially result in hMPV false positives.

    Code Info

    UDI-DI: 00840487100417. Lot/Expiration: IK051C-0181/ 9/30/2024, IK051C-0182/ 9/30/2024, IK051C-0185/ 9/30/2024, IK051C-0186/ 9/30/2024, IK051C-0187/ 10/31/2024, IK051C-0188/ 10/31/2024, IK051C-0189/ 10/31/2024, IK051C-0190/ 10/31/2024, IK051C-0191/ 10/31/2024, IK051C-0192/ 10/31/2024, IK051C-0193/ 10/31/2024, IK051C-0194/ 10/31/2024, IK051C-0195/ 10/31/2024, IK051C-0196/ 11/30/2024, IK051C-0197/ 12/31/2024

    Distribution

    U Nationwide distribution in the states of OH, CA, NC, WI, TN, TX, MI, NY, MO, FL, MA, NJ, PA, VA, AZ, IL, OK, CO, MN.

    Quantity

    3375