BEUDAMED
    FDA Enforcement Class I Ongoing

    COVID-19 Self-Test Kit *** INNOVA *** 7T

    Recall: Z-1537-2021 · Reported June 16, 2021

    Enforcement

    Recall Number
    Z-1537-2021
    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

    COVID-19 Self-Test Kit *** INNOVA *** 7T

    Reason

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

    Code Info

    Catalog Number: 7T Lot Numbers: U2101748 U2102001 U2102002 X2012711 X2103792

    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

    370 boxes (=2,590 individual tests)