BEUDAMED
    FDA Enforcement Class II Ongoing

    Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R

    Recall: Z-0920-2022 · Reported April 20, 2022

    Enforcement

    Recall Number
    Z-0920-2022
    Event ID
    89051
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Luminex Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    April 20, 2022
    Initiation Date
    April 22, 2019
    Classification Date
    April 13, 2022
    Address
    4088 Commercial Ave, N/A, Northbrook, IL, 60062-1829, United States

    Description

    Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R

    Reason

    Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question.

    Code Info

    Model Number 10-0000-07, Serial Numbers: 13042054,16347082,17215010; Model Number 10-0000-07-R, Serial Numbers: 18079010

    Distribution

    US: TX, CT, LA

    Quantity

    4 units