BEUDAMED
    FDA Recall Terminated

    VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria.

    Recall: Z-0445-2019 · Initiated September 14, 2018

    Recall

    Recall Number
    Z-0445-2019
    Event Number
    81220
    Firm
    Luminex Corporation
    FEI Number
    3002524000
    Product Code
    PAM
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 14, 2018
    Posted
    November 10, 2018
    Terminated
    April 28, 2021
    Address
    12212 Technology Blvd, Austin, TX, 78727-6101

    Description

    VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria.

    Reason

    Potential to lead to a false negative results.

    Action

    On September14, 2018, Luminex sent Urgent Customer Advisory Notifications to their consignees. The letter identified the affected product, problem and actions to be taken. For questions contact Customer Experience Team.

    Distribution

    Worldwide Distribution - US Nationwide in the states of United States - AZ, CA, CO, CT, DC, FL, GA,, IA, ID, IN, KA,, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NV, NJ, NY, OK,,OH, OR, PA, SC, TN, TX, UT, VT, WA, KS, and VA.. France

    Quantity

    12,700 trays