BEUDAMED
    FDA Enforcement Class II Terminated

    FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood. Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. (CLIA Waived Laboratories)

    Recall: Z-2408-2021 · Reported September 8, 2021

    Enforcement

    Recall Number
    Z-2408-2021
    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

    FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood. Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. (CLIA Waived Laboratories)

    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