BEUDAMED
    FDA Recall Open, Classified

    Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test

    Recall: Z-2533-2024 · Initiated June 20, 2024

    Recall

    Recall Number
    Z-2533-2024
    Event Number
    94970
    Firm
    Luminex Corporation
    FEI Number
    3006028115
    Product Code
    PAM
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    June 20, 2024
    Posted
    August 8, 2024
    Address
    4088 Commercial Ave, Northbrook, IL, 60062-1829

    Description

    Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test

    Reason

    Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.

    Action

    Diasorin sent a recall notification on 06/20/2024, via email. Consignees were instructed to examine inventory and quarantine any affected units, arrange for replacement and confirm disposal of any of affected units on hand. Customers were asked to perform a retrospective review of results for VERIGENE Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) to look for any false positives, distribute the notification to any relevant personnel, notify consignees if further distributed and complete and return the "Acknowledgement & Receipt Form."

    Distribution

    US Nationwide distribution including in the states of AZ, CA, CO, DE, FL, GA, IA, IL, KY, MD, MI, MN, MO, MS, NE, NV, OH, OK, SC, TN, TX, VA, VT, WA, WV.

    Quantity

    1,100 kits