BEUDAMED
    FDA Adverse Event Other Summary report: N

    FLOWFLEX COVID-19 ANTIGEN HOME TEST

    MDR report key: 17584939 · Received August 18, 2023

    Report

    Report Number
    MW5144765
    Event Type
    Other
    Date Received
    August 18, 2023
    Date of Event
    August 16, 2023
    Report Date
    August 16, 2023
    Manufacturer
    ACON LABORATORIES, INC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I PURCHASED FLOWFLEX ANTIGEN HOME TEST LOT COV1120162, EXPIRATION DATE INDICATED ON A BOX IS 2023-09-16. IN THE BOX I FOUND THAT BOTH EXTRACTION BUFFER AND TEST CASSETTES ARE LONG EXPIRED: EXTRACTION BUFFER TUBES, LOT 211125026, EXP.2023-05-24 AND THE TEST CASSETTES LOT COV1120162, EXP 2021-12-16.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725208 FLOWFLEX COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ACON LABORATORIES, INC. 00682607660285 COV1120162

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Other