BEUDAMED
    FDA Enforcement Class II Ongoing

    NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468

    Recall: Z-0043-2025 · Reported October 16, 2024

    Enforcement

    Recall Number
    Z-0043-2025
    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 +SARS-CoV-2, REF: I056C0468

    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

    Lot/Expiration: IK056C-0033/ 9/30/2024, IK056C-0034/ 10/31/2024, IK056C-0035/ 10/31/2024, IK056C-0036/ 12/31/2024, IK056C-0037/ 12/31/2024, IK056C-0038/ 12/31/2024, IK056C-0039/ 1/31/2025

    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

    613