BEUDAMED
    FDA Enforcement Class I Ongoing

    Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test

    Recall: Z-1044-2022 · Reported May 18, 2022

    Enforcement

    Recall Number
    Z-1044-2022
    Event ID
    89995
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Woodside Acquisitions Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 18, 2022
    Initiation Date
    April 9, 2022
    Classification Date
    May 12, 2022
    Address
    1625 Lincoln Ave., N/A, tyrone, PA, 16686, United States

    Description

    Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test

    Reason

    Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States.

    Code Info

    All lots

    Distribution

    US distributions to states of: AL and GA.

    Quantity

    34,240 units