BEUDAMED
    FDA Enforcement Class I Terminated

    E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit

    Recall: Z-0564-2022 · Reported February 16, 2022

    Enforcement

    Recall Number
    Z-0564-2022
    Event ID
    89485
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    E25Bio, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 16, 2022
    Initiation Date
    January 27, 2022
    Classification Date
    February 9, 2022
    Termination Date
    September 19, 2022
    Address
    501 Massachusetts Ave, The Engine, Cambridge, MA, 02139-4018, United States

    Description

    E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit

    Reason

    The Test is not authorized, cleared, or approved by FDA for clinical diagnostic or screening purposes. It was distributed without sufficient directions or controls in place.

    Code Info

    Lot numbers are unavailable. The following Purchase Orders and Dates are affected: Purchase Order/Invoice Number Date 1006 10/13/2020 1007 11/13/2020 1008 11/25/2020 1009 12/18/2020 1010 01/07/2021 1011 01/07/2021 1012 01/07/2021 1011 01/07/2021 1015 1/29/2021 1016 02/03/2021 1019 2/26/2021 1017 2/23/2021 1021 3/05/2021 1023 3/19/2021 1027 04/05/2021 1039 11/03/2021 1040 11/03/2021 1028 4/16/2021 1029 5/10/2021 1032 09/03/2021 1073 11/27/2020

    Distribution

    US Nationwide distribution in the states of MA, FL, and HI.

    Quantity

    73,300 units