BEUDAMED
    FDA Enforcement Class II Ongoing

    VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022

    Recall: Z-2024-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-2024-2023
    Event ID
    92451
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Luminex Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 5, 2023
    Initiation Date
    June 5, 2023
    Classification Date
    June 28, 2023
    Address
    4088 Commercial Ave, N/A, Northbrook, IL, 60062-1829, United States

    Description

    VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022

    Reason

    It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could provide a false-negative result due to hydrophobic characteristics in specific FLOQSwab lots.

    Code Info

    UDI/DI , Lot Numbers: 071222022D, 100622022D

    Distribution

    Worldwide and US Nationwide Distribution

    Quantity

    114 units