BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0498-2022 · Initiated April 16, 2021

    Recall

    Recall Number
    Z-0498-2022
    Event Number
    89303
    Firm
    Luminex Corporation
    FEI Number
    3002524000
    Product Code
    OOI
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    April 16, 2021
    Terminated
    September 20, 2024
    Address
    12212 Technology Blvd, Austin, TX, 78727-6101

    Description

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

    Reason

    Impacted lot may leak inside the ARIES instrument.

    Action

    On 04/16/2021, the firm notified affected customers via email using a letter titled, "URGENT: MEDICAL DEVICE RECALL ARIES HSV 1&2 Assay." The letter indicated the following: " Please inform all those who need to be aware within your organization of this potential product performance issue. At this time, you should destroy any inventory of these ARIES HSV 1&2 Assays. Please follow the "Steps in Voluntary Recall" directions found on the following pages of this notification. The Acknowledgment and Receipt Form must be completed and returned, even if you do not have any remaining product, by April 26th, 2021. We appreciate your assistance with this matter. Please call Luminex's Global Support Services if you have any questions or concerns. Luminex Global Support Services 1-877-785-2323 (U .S. and Canada) +1-512-381-4397 (Outside U.S. and Canada) [email protected] CAN-0282, Rev A

    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