BEUDAMED
    FDA Enforcement Class II Ongoing

    Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system

    Recall: Z-1092-2022 · Reported May 25, 2022

    Enforcement

    Recall Number
    Z-1092-2022
    Event ID
    90023
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Luminex Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 25, 2022
    Initiation Date
    April 5, 2022
    Classification Date
    May 13, 2022
    Address
    12212 Technology Blvd, N/A, Austin, TX, 78727-6101, United States

    Description

    Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system

    Reason

    Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.

    Code Info

    Serial Numbers for 10-0000-07: 17340003 19044007 20133004 18128002 18214004 12061048 18191010 13193254 13051068 21029902 16277059 19233005 11250096 14069051 18255003 *18039010 *20212006 *19317004 *19206009 *18057008 Serial Numbers added 6.23.22 for 10-0000-07R: 18191010 13051068 14069051 *12198198 *12278344 *14322267 *12271338 Serial Numbers added 7.14.22 for 10-0000-07R: 18226007 and 16242043 Serial Numbers added 7.14.22 for 10-0000-07: 17062030, 18235008 and 19192006

    Distribution

    US:OH, ME, PA, FL, IL, NE, IN, TX, GA, WA, MI, CO, AZ, OH, KY, CA, VT OUS: None

    Quantity

    24 units