BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-2310-2021 · Reported August 25, 2021

    Enforcement

    Recall Number
    Z-2310-2021
    Event ID
    88344
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    OPTI Medical Systems, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 25, 2021
    Initiation Date
    June 25, 2021
    Classification Date
    August 17, 2021
    Address
    235 Hembree Park Dr, N/A, Roswell, GA, 30076-5738, United States

    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.

    Code Info

    a) 99-57003, Lot Numbers: 20808, 20812, 20813 b) 99-57004, Lot Numbers: 20881, 20901, 211013

    Distribution

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

    Quantity

    3552 kits