BEUDAMED
    FDA Recall Open, Classified

    Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Luminex VERIGENE BC-GP Utility Kit, REF 20-012-018, containing 20 tests.

    Recall: Z-0500-2024 · Initiated November 7, 2023

    Recall

    Recall Number
    Z-0500-2024
    Event Number
    93364
    Firm
    Luminex Corporation
    FEI Number
    3006028115
    Product Code
    PAM
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    November 7, 2023
    Posted
    December 6, 2023
    Address
    4088 Commercial Ave, Northbrook, IL, 60062-1829

    Description

    Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Luminex VERIGENE BC-GP Utility Kit, REF 20-012-018, containing 20 tests.

    Reason

    Potentially defective utility trays in the reagent kits.

    Action

    The recalling firm issued letters dated 11/7/2023 via email on the same date. The letter explained the reason for recall, risk to health, and actions to be taken by the consignee/distributor. The actions included examining their inventory for the affected product, cease all use, and isolate or quarantine the product pending disposal; contact Luminex Global Support Services to arrange for replacement and confirm the disposal of any remaining kits in inventory; perform a retrospective review of results for VERIGENE Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) and if false negative results with a patient sample tested with the affected lot number have been encountered, contact Luminex Global Support; distribute the notification to any individuals within their organization who need to be made aware of the recall; if the consignee is a distributor, they are to provide a copy of this letter to any customers or organizations who may have received the affected lot number; and complete the enclosed Acknowledgement & Receipt Form and return it to Luminex Technical Support.

    Distribution

    Worldwide - US Nationwide distribution in the states of AZ, CA, CO, DE, FL, GL, IL, IN, MA, MD, MI, MN, MO, MS, NE, NY, OH, OK, OR, TN, TX, UT, VA, WA, and WI. The country of Italy.

    Quantity

    222 kits (4,440 trays)