BEUDAMED
    FDA Enforcement Class II Terminated

    ARIES HSV 1&2 Assay, Catalog/REF# 50-10017

    Recall: Z-0553-2022 · Reported February 9, 2022

    Enforcement

    Recall Number
    Z-0553-2022
    Event ID
    89244
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Luminex Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 9, 2022
    Initiation Date
    November 17, 2021
    Classification Date
    February 2, 2022
    Termination Date
    July 8, 2024
    Address
    12212 Technology Blvd, N/A, Austin, TX, 78727-6101, United States

    Description

    ARIES HSV 1&2 Assay, Catalog/REF# 50-10017

    Reason

    Impacted lot may leak inside the ARIES instrument. Testing confirmed a leak rate of 0.9%. Leaking cassettes could potentially lead to incorrect results or a delay in reporting results due to an Invalid.

    Code Info

    Lot Numbers AB3600A and AB3560A

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of New Jersey, California, Connecticut, Minnesota, Missouri, New Jersey, New Mexico, Pennsylvania, Tennessee, Washington, and Wisconsin) and the country of Malaysia.

    Quantity

    329