BEUDAMED
    FDA Enforcement Class II Ongoing

    VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021

    Recall: Z-1109-2022 · Reported May 25, 2022

    Enforcement

    Recall Number
    Z-1109-2022
    Event ID
    90129
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Luminex Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 25, 2022
    Initiation Date
    February 15, 2022
    Classification Date
    May 17, 2022
    Address
    4088 Commercial Ave, N/A, Northbrook, IL, 60062-1829, United States

    Description

    VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021

    Reason

    Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.

    Code Info

    Lot Number 101321021B

    Distribution

    US

    Quantity

    984 units