BEUDAMED
    FDA Enforcement Class II Ongoing

    ARIES SARS-CoV-2 Assay

    Recall: Z-1524-2022 · Reported August 24, 2022

    Enforcement

    Recall Number
    Z-1524-2022
    Event ID
    90698
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Luminex Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 24, 2022
    Initiation Date
    July 14, 2022
    Classification Date
    August 17, 2022
    Address
    12212 Technology Blvd, Austin, TX, 78727-6101, United States

    Description

    ARIES SARS-CoV-2 Assay

    Reason

    SARS-CoV-2 assay that detects SARS-CoV-2 ORF1ab and N genes may not detect the ORF1ab gene. A positive results if either SARS-CoV-2 genes is detected, but If both genes are mistakenly not detected, a false negative result would be generated.

    Code Info

    Lot: AB4042A

    Distribution

    U.S. Nationwide distribution in the states of NE, TX, MS, TN, KY, ME, CA.

    Quantity

    257