BEUDAMED
    FDA Enforcement Class II Terminated

    Assure COVID-19 IgG/IgM Rapid Test Device that include: 1) Pouch Label - FaStep Rapid Diagnostic Test *** Rapid Reliable Simple *** COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) *** For Emergency Use Authorization Only, Box Label - FaStep Rapid Diagnostic Test *** COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) *** For Emergency Use Authorization Only *** For in vitro diagnostic use only, and 2) Pouch Label - ECOTEST RAPID DIAGNOSTIC TEST *** /Rapid / Reliable / Simple/ *** COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) *** For Emergency Use Authorization Only, Box Label - ECOTEST RAPID DIAGNOSTIC TEST *** Rapid Reliable Simple *** COVID-19 IgG/IgM Rapid Test Device *** For Professional in vitro diagnostic use only *** For Emergency Use Authorization Only.

    Recall: Z-1432-2021 · Reported April 28, 2021

    Enforcement

    Recall Number
    Z-1432-2021
    Event ID
    87541
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    AZURE BIOTECH INC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 28, 2021
    Initiation Date
    March 2, 2021
    Classification Date
    April 16, 2021
    Termination Date
    March 31, 2023
    Address
    5250 Gulfton St Ste 2c, N/A, Houston, TX, 77081-2936, United States

    Description

    Assure COVID-19 IgG/IgM Rapid Test Device that include: 1) Pouch Label - FaStep Rapid Diagnostic Test *** Rapid Reliable Simple *** COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) *** For Emergency Use Authorization Only, Box Label - FaStep Rapid Diagnostic Test *** COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) *** For Emergency Use Authorization Only *** For in vitro diagnostic use only, and 2) Pouch Label - ECOTEST RAPID DIAGNOSTIC TEST *** /Rapid / Reliable / Simple/ *** COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) *** For Emergency Use Authorization Only, Box Label - ECOTEST RAPID DIAGNOSTIC TEST *** Rapid Reliable Simple *** COVID-19 IgG/IgM Rapid Test Device *** For Professional in vitro diagnostic use only *** For Emergency Use Authorization Only.

    Reason

    Due to Products being incorrect labeling "for diagnostic use" and labelled with an unsupported 24 month expiration dating.

    Code Info

    Lot Numbers: I2004001, I2004003, I2006128, I2005023, and I2006030

    Distribution

    Worldwide distribution - U.S. Nationwide distribution in the states of CA. FL, GA, IL, LA, MD, MN, NC, TX, UT, VA and WA. The country of Canada.

    Quantity

    Total 100,000 kits (FaStep and EcoTest Rapid Diagnostic Test kits)