BEUDAMED
    FDA Recall Open, Classified

    Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green and white box under the brand DiagnosUS, and, White box without brand name labeled as "SARS -COV-2 ANTIGEN DEVELOPMENT MADE IN USA ORAL SWAB TESTING

    Recall: Z-0929-2023 · Initiated November 28, 2022

    Recall

    Recall Number
    Z-0929-2023
    Event Number
    91321
    Firm
    Universal Meditech Inc.
    FEI Number
    3011908678
    Product Code
    QKP
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    November 28, 2022
    Posted
    January 27, 2023
    Address
    1320 E Fortune Avenue, Suite 102, Fresno, CA, 93725

    Description

    Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green and white box under the brand DiagnosUS, and, White box without brand name labeled as "SARS -COV-2 ANTIGEN DEVELOPMENT MADE IN USA ORAL SWAB TESTING

    Reason

    Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use Authorization.

    Action

    On 12/29/2022, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via email to customers informing them Universal Meditech Inc. is recalling SARS-CoV-2 Antigen Rapid Test Kits due to test kits being distributed with any FDA pre-market approvals, clearances and/or authorizations. Test kits are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits, or labelled and packaged in Green and white box under the brand name DiagnosUS, or packaged in White box without brand name labeled as "SARS -COV-2 ANTIGEN DEVELOPMENT MADE IN USA ORAL SWAB TESTING. Customer are instructed to: -Immediately stop distributing or using any of the abovementioned device in their remaining stock. -If they have already distributed the device to anyone else, please inform them of the product recall by forwarding this letter to them. -Acknowledge receipt of this recall notification by filling out the attached form at the end of this letter and sending back to Universal Meditech, so that arrangements can be made to refund or an order replacement using FDA authorized devices. Note- this recall is for ALL devices under this trade name, regardless of their lot number and date of manufacture. For questions or assistance with this recall, contact Michael M. Lin, Legal Attorney Email: [email protected] or Tel: +1(702)871-9888 (9AM to 5PM, PST, MON to FRI)

    Distribution

    U.S. Nationwide distribution in the states of CA, and TX.

    Quantity

    56,300 kits