BEUDAMED
    FDA Enforcement Class II Terminated

    First SIGN SARS-CoV-2 Antigen Test

    Recall: Z-0892-2022 · Reported April 13, 2022

    Enforcement

    Recall Number
    Z-0892-2022
    Event ID
    89676
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    WHPM Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 13, 2022
    Initiation Date
    March 4, 2022
    Classification Date
    April 7, 2022
    Termination Date
    February 5, 2025
    Address
    5358 Irwindale Ave Ste B, Irwindale, CA, 91706-2086, United States

    Description

    First SIGN SARS-CoV-2 Antigen Test

    Reason

    Frm became aware that a customer complaint was reported to US FDA that SARS-CoV-2 Antigen Tests were sold domestically by a pharmacy in California. These Antigen Tests have not received FDA Emergency Use Authorization, nor have these tests been cleared or approved by FDA for commercial distribution in the U.S.

    Code Info

    Model Number: FSSA-CK20 UDI Codes: None Lot Numbers: F0301214078; F1227210039; F0809210004; F0906210010; P0211214070; F0914210014; F1013210020; F1214210034; F0121220041;

    Distribution

    U.S.: CA, FL, LA, MA and TX O.U.S.: N/A

    Quantity

    535,755 tests