BEUDAMED
    FDA Enforcement Class II Terminated

    Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCC)V-402a - Product Usage: is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV- 2 in human venous whole blood, plasma from anticoagulated blood or serum.

    Recall: Z-1125-2021 · Reported February 24, 2021

    Enforcement

    Recall Number
    Z-1125-2021
    Event ID
    87263
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Confirm Biosciences Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 24, 2021
    Initiation Date
    January 29, 2021
    Classification Date
    February 16, 2021
    Termination Date
    December 13, 2022
    Address
    10123 Carroll Canyon Rd, N/A, San Diego, CA, 92131-1109, United States

    Description

    Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCC)V-402a - Product Usage: is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV- 2 in human venous whole blood, plasma from anticoagulated blood or serum.

    Reason

    Due to two (2) issues: 1) The firm distributed COVID-19 Rapid Test Cassettes outside of the Emergency Use Authorization to non-certified Clinical Laboratories. 2) COVID-19 Rapid Test Cassettes were not adequately validated for its intended use (fingerstick tests for in-home use/testing).

    Code Info

    Catalog Number: HE Cassette COVID 19EUA Lot Numbers: 2006167eua 2006168eua 2006169eua

    Distribution

    Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY. The countries of Australia, Mexico, Honduras, Spain, Sierra Leone, Bahamas, Ecuador, Turkey, Romania, Kuwait, Libya, Qatar, Ghana, Argentina, Bolivia, Brazil, Guatemala, Panama, India, United Kingdom, West Indies, South Africa, United Arab Emirates, Slovenia, Canada, Israel, United Kingdom, Romania, Argentina, Honduras, Russian Federation, R¿publique D¿mocratique du Congo, Switzerland, Dominican Republic, Greece, Saudi Arabia, and Portugal.

    Quantity

    563,840 cassettes