BEUDAMED
    FDA Enforcement Class II Ongoing

    ARIES SARS-CoV-2 Assay, REF: 50-10047

    Recall: Z-0134-2023 · Reported November 2, 2022

    Enforcement

    Recall Number
    Z-0134-2023
    Event ID
    90937
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Luminex Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 2, 2022
    Initiation Date
    September 14, 2022
    Classification Date
    October 26, 2022
    Address
    12212 Technology Blvd, N/A, Austin, TX, 78727-6101, United States

    Description

    ARIES SARS-CoV-2 Assay, REF: 50-10047

    Reason

    A part defect with the wash 1 syringe of an SARS-CoV-2 assay could lead to incomplete extraction thereby producing an invalid or false negative assay result.

    Code Info

    Lot - Expiration: AB4723A - 05/25/2022, AB5041A - 05/25/2022, AB5060A - 06/01/2022, AB5061A - 06/06/2022, AB5081A - 06/07/2022, AB5139A - 09/10/2022, AB5141A - 09/16/2022, AB5263A - 09/27/2022, AB5282A - 10/05/2022, AB6640A - 06/8/2023, AB6720A - 06/13/2023

    Distribution

    Distribution US nationwide, Indonesia, and Hong Kong.

    Quantity

    5,141 (24 Cassettes)