BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1109-2022 · Initiated February 15, 2022

    Recall

    Recall Number
    Z-1109-2022
    Event Number
    90129
    Firm
    Luminex Corporation
    FEI Number
    3006028115
    Product Code
    PEP
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    February 15, 2022
    Address
    4088 Commercial Ave, Northbrook, IL, 60062-1829

    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.

    Action

    Luminex sent a product recall notice on 02/15/2022 by email. The notice informed the user of "No Call Internal Control failures" and requested that they contact Luminex Global Support Services at [email protected] to arrange for replacement and confirm the disposal of any kits in inventory.

    Distribution

    US

    Quantity

    984 units