BEUDAMED
    FDA Enforcement Class I Ongoing

    For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BT1309

    Recall: Z-1538-2021 · Reported June 16, 2021

    Enforcement

    Recall Number
    Z-1538-2021
    Event ID
    87682
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    INNOVA MEDICAL GROUP, INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 16, 2021
    Initiation Date
    April 9, 2021
    Classification Date
    June 10, 2021
    Address
    800 E Colorado Blvd Ste 200, N/A, Pasadena, CA, 91101-5401, United States

    Description

    For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BT1309

    Reason

    Due to distributing test kits to customers who were not part of a clinical investigation.

    Code Info

    Catalog Number: 25T REF: Bt1309 Lot Numbers: U2101750 U2101751 X2006004 X2008001 X2008010 X2009002 X2009004 X2009013 X2009016 X2010004 X2010010 X2011005 X2011006 X2011007 X2011008 X2011009 X2011012 X2011013 X2011015 X2011016 X2011017 X2011025 X2011051 X2011052 X2012001 X2012002 X2012004 X2012005 X2012008 X2101002 X2101004 X2101014 X2101031 X2101038

    Distribution

    Worldwide distribution - U.S. Nationwide in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, PA, RI, TN, TX, UT, VA, VT, WA, and WI. The countries of Canada, India and United Kingdom.

    Quantity

    1,945 boxes (=48,625 individual tests)