BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-0054-2021 · Reported October 14, 2020

    Enforcement

    Recall Number
    Z-0054-2021
    Event ID
    86358
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Luminex Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    October 14, 2020
    Initiation Date
    December 10, 2018
    Classification Date
    October 5, 2020
    Address
    12212 Technology Blvd, N/A, Austin, TX, 78727-6101, United States

    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.

    Code Info

    Catalogue Number: 10-0000-07 Serial No. 14230205 UDI Code: 00857573006010

    Distribution

    US distribution in MO. No OUS

    Quantity

    1 system