BEUDAMED
    FDA Recall Open, Classified

    Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023

    Recall: Z-2023-2023 · Initiated June 5, 2023

    Recall

    Recall Number
    Z-2023-2023
    Event Number
    92451
    Firm
    Luminex Corporation
    FEI Number
    3006028115
    Product Code
    PCH
    Status
    Open, Classified
    Root Cause
    Other
    Initiated
    June 5, 2023
    Posted
    June 28, 2023
    Address
    4088 Commercial Ave, Northbrook, IL, 60062-1829

    Description

    Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023

    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.

    Action

    Luminex issued an Urgent Field Safety Notice - Medical Device Recall notice on 06/05/2023 by email. The notice explained the problem with the stool prep kit, the risk, and requested isolation/quarantine, cease of use, and disposal of the affected products.

    Distribution

    Worldwide and US Nationwide Distribution

    Quantity

    3987 units