BEUDAMED
    FDA Enforcement Class II Terminated

    ARIES HSV 1&2 Assay, Part Number/REF 50-10017

    Recall: Z-0498-2022 · Reported January 26, 2022

    Enforcement

    Recall Number
    Z-0498-2022
    Event ID
    89303
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Luminex Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 26, 2022
    Initiation Date
    April 16, 2021
    Classification Date
    January 14, 2022
    Termination Date
    September 20, 2024
    Address
    12212 Technology Blvd, N/A, Austin, TX, 78727-6101, United States

    Description

    ARIES HSV 1&2 Assay, Part Number/REF 50-10017

    Reason

    Impacted lot may leak inside the ARIES instrument.

    Code Info

    Lot number AB1703A

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of Alabama, California, Georgia, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New Mexico, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Vermont, Virginia, Washington, Wisconsin and the country of Taiwan.

    Quantity

    296 kits