BEUDAMED
    FDA Enforcement Class II Terminated

    Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in human venous whole blood, plasma (Li+- heparin, K2-EDTA and sodium-citrate), and serum. Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories. Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform moderate or high complexity tests

    Recall: Z-2409-2021 · Reported September 8, 2021

    Enforcement

    Recall Number
    Z-2409-2021
    Event ID
    88429
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Versea Diagnostics LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 8, 2021
    Initiation Date
    July 27, 2021
    Classification Date
    September 2, 2021
    Termination Date
    April 10, 2024
    Address
    1000 N Florida Ave, N/A, Tampa, FL, 33602-3808, United States

    Description

    Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in human venous whole blood, plasma (Li+- heparin, K2-EDTA and sodium-citrate), and serum. Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories. Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform moderate or high complexity tests

    Reason

    Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authorization.

    Code Info

    all lot codes

    Distribution

    US Nationwide Distribution: AL, AZ, CA, CO, CT, FL, GA, IL, KS, OH, OK, MA, MD, MI, NC, NJ, NY, PA, SC, TX, VA, and WA.

    Quantity

    563,290 in total