BEUDAMED
    FDA Recall Open, Classified

    VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids

    Recall: Z-0054-2021 · Initiated December 10, 2018

    Recall

    Recall Number
    Z-0054-2021
    Event Number
    86358
    Firm
    Luminex Corporation
    FEI Number
    3002524000
    Product Code
    OCC
    Status
    Open, Classified
    Root Cause
    Component design/selection
    Initiated
    December 10, 2018
    Address
    12212 Technology Blvd, Austin, TX, 78727-6101

    Description

    VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids

    Reason

    No results/incorrect results due to failure of the hybridization heater.

    Action

    On or about 11/19/2018 there was one complaint from a customer regarding a thermal control failure. In response to the complaint the Field Service Engineer replaced hybridization heater and ran all tests as passed. Subsequently, the customer reported the initial service was ineffective. The VERIGENE SP Processor was then removed from the customer site and returned for analysis. No Customer Notification was communicated for this removal.

    Distribution

    US distribution in MO. No OUS

    Quantity

    1 system