BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0920-2022 · Initiated April 22, 2019

    Recall

    Recall Number
    Z-0920-2022
    Event Number
    89051
    Firm
    Luminex Corporation
    FEI Number
    3006028115
    Product Code
    NSU
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 22, 2019
    Address
    4088 Commercial Ave, Northbrook, IL, 60062-1829

    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.

    Action

    The firm sent technicians to sites beginning on 13 March 2019 to test the devices and the devices were subsequently returned. The firm send a notice regarding the recall on 03/10/2022 by email. The notices documented the actions of the firm with respect to the devices.

    Distribution

    US: TX, CT, LA

    Quantity

    4 units