BEUDAMED
    FDA Enforcement Class II Completed

    VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnostic test

    Recall: Z-1903-2025 · Reported June 11, 2025

    Enforcement

    Recall Number
    Z-1903-2025
    Event ID
    96701
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Luminex Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 11, 2025
    Initiation Date
    April 16, 2025
    Classification Date
    June 3, 2025
    Address
    4088 Commercial Ave, N/A, Northbrook, IL, 60062-1829, United States

    Description

    VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnostic test

    Reason

    It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small portion of the lot of test cartridges.

    Code Info

    UDI/DI 00840487101599, Lot Number 022525021A, exp. 08/26/2025

    Distribution

    US Nationwide distribution in the states of AL, CA, MN, TX, AZ, NJ, WA, SC, VA, GA, VT, CT, MD.

    Quantity

    89 units