BEUDAMED
    FDA Enforcement Class II 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 · Reported November 21, 2018

    Enforcement

    Recall Number
    Z-0445-2019
    Event ID
    81220
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Luminex Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 21, 2018
    Initiation Date
    September 14, 2018
    Classification Date
    November 9, 2018
    Termination Date
    April 28, 2021
    Address
    12212 Technology Blvd, Austin, TX, 78727-6101, United States

    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.

    Code Info

    Supplier raw tray lots 195916-070518 and 190943-073118 Utility Tray Lots: 082518018C, 081618018C, 082918018C, 090418018B, 081118018C and 082718018B

    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