BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOWFLEX COVID-19 ANTIGEN HOME TEST

    MDR report key: 17975381 · Received October 19, 2023

    Report

    Report Number
    MW5147163
    Event Type
    Injury
    Date Received
    October 19, 2023
    Date of Event
    October 16, 2023
    Report Date
    October 16, 2023
    Manufacturer
    ACON LABORATORIES, INC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DEFECTIVE ACON LABORATORIES, INC. FLOWFLEX COVID-19 ANTIGEN HOME TEST MADE IN CHINA L031329-01 LOT COV2010015 DISTRIBUTED BY HARRIS TEETER PHARMACY (B)(6) WITH MANUFACTURE DATE 2022-01-07 AND EXPIRATION DATE OF 2023-01-06 BUT APPROVED BY FDA FOR 1 YEAR EXTENSION OF EXPIRATION DATE. TEST KITS DO NOT EXHIBIT A CONTROL LINE AND THEREFORE ARE DEFECTIVE AND UNUSABLE THEREBY CREATING A LIFE/THREATENING CONDITION IF USED UNDER FDA APPROVED EXPIRATION DATE EXTENSION. IMMEDIATE RECALL REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1996123 FLOWFLEX COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACON LABORATORIES, INC. COV2010015

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Unknown Life Threatening