BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVID TEST KIT FLOWFLEX

    MDR report key: 24703834 · Received March 26, 2026

    Report

    Report Number
    MW5185988
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Report Date
    March 24, 2026
    Manufacturer
    ACON LABORATORIES, INC.
    Product Code
    QYT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    HAVE BOUGHT THROUGH AMAZON A COUNTERFEIT FLOW FLEX COVID TEST KIT. THE OUTSIDE PACKAGING APPEARED LEGITIMATE BUT COULD HAVE BEEN COUNTERFEITED THE INSIDE CONTENTS ARE DEFINITELY COUNTERFEIT OUTSIDE BOX- LOT COV4105014 REF L031-118P5 (B)(6) ACON BIOTECH (HANGZHOU) CO.., LTD NO 210 ZHENZHONG ROAD, WEST LAKE DISTRICT , HANGZHOU OR CHINA 310030 MEDNET EC-REP GMBH BORKSTRASSE 10, 48163 MUENSTER, GERMANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756406 COVID TEST KIT FLOWFLEX OVER-THE-COUNTER COVID-19 ANTIGEN TEST QYT ACON LABORATORIES, INC. 1130522808 COV4105014

    Patients

    Seq Age Sex Outcome Treatment
    1 Female