BEUDAMED
    FDA Recall Open, Classified

    ARIES SARS-CoV-2 Assay

    Recall: Z-1524-2022 · Initiated July 14, 2022

    Recall

    Recall Number
    Z-1524-2022
    Event Number
    90698
    Firm
    Luminex Corporation
    FEI Number
    3002524000
    Product Code
    QJR
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 14, 2022
    Address
    12212 Technology Blvd, Austin, TX, 78727-6101

    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.

    Action

    On 7/14/22 recall notices were emailed to consignees who were asked to review any results from the affected lot to confirm the validity of the results. In addition, all remaining cassettes from this lot should be discarded. Customers with questions are encouraged to contact the firm at: 1-877-785-2323 (U.S. and Canada), +1-512-381-4397 (Outside U.S. and Canada), [email protected]

    Distribution

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

    Quantity

    257