BEUDAMED
    FDA Recall Open, Classified

    OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004

    Recall: Z-2310-2021 · Initiated June 25, 2021

    Recall

    Recall Number
    Z-2310-2021
    Event Number
    88344
    Firm
    OPTI Medical Systems, Inc
    FEI Number
    3004102403
    Product Code
    QJR
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 25, 2021
    Address
    235 Hembree Park Dr, Roswell, GA, 30076-5738

    Description

    OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004

    Reason

    The firm identified a precipitation issue which may cause late Ct reactors (a false positive result) with a rate of 5 to 10% for affected vials of RNA Master Mix.

    Action

    /The firm disseminated a technical bulletin beginning on 06/25/2021 by email identifying the /problem and providing additional instructions to be implemented when using the product.

    Distribution

    Maine, New York, Alabama, Pennsylvania, Florida, Illinois, New Jersey, Connecticut, Georgia, Puerto Rico, Costa Rica, Hong Kong, Philippines, Barbados

    Quantity

    3552 kits