BEUDAMED
    FDA Enforcement Class II Ongoing

    Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked

    Recall: Z-0945-2022 · Reported April 27, 2022

    Enforcement

    Recall Number
    Z-0945-2022
    Event ID
    89755
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Acon Biotech (Hangzhou) Co., Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 27, 2022
    Initiation Date
    January 9, 2022
    Classification Date
    April 15, 2022
    Address
    398 Tianmushan Road, Hangzhou, N/A, China

    Description

    Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked

    Reason

    Non-EUA authorized, CE marked, SARS-CoV-2 antigen rapid test kits are being recalled from the U.S. market because use may lead to inaccurate test results, including false negative or false positive test results.

    Code Info

    Lots: COV1080201, COV1105014

    Distribution

    US: MD, PA International Distribution to countries of: Hungary and China.

    Quantity

    303,760