BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWFLEX SARS-COV-2 ANTIGEN RAPID TEST (SELF-TESTING)

    MDR report key: 13862016 · Received March 22, 2022

    Report

    Report Number
    MW5108408
    Event Type
    Malfunction
    Date Received
    March 22, 2022
    Date of Event
    December 23, 2021
    Report Date
    March 21, 2022
    Manufacturer
    ACON BIOTECH / ACON LABORATORIES, INC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2021 I BOUGHT 4 FLOWFLEX COVID-19 SINGLE TEST KITS FROM (B)(6). MY DAUGHTER TOOK ONE AND IT WAS NEGATIVE. I TOOK ANOTHER IN (B)(6) 2022 AND IT WAS NEGATIVE. IN (B)(6) I SAW THAT THESE (BLUE BOXES) HAD BEEN RECALLED. APPARENTLY THEY ARE COUNTERFEIT, ACCORDING TO ACON LABS WEBSITE? AS I READ THE RECALL, THE FDA WANTED ALL DISTRIBUTION OF THESE REPORTED. I AM HOPING THAT I CAN RETURN THE TWO I HAVE LEFT TO (B)(6) FOR A REFUND, BUT WILL WAIT IN CASE THE FDA WANTS THE TESTS AND THE RECEIPT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304409 FLOWFLEX SARS-COV-2 ANTIGEN RAPID TEST (SELF-TESTING) CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACON BIOTECH / ACON LABORATORIES, INC. COV1105014
    304410 FLOWFLEX SARS-COV-2 ANTIGEN RAPID TEST (SELF-TESTING) CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACON BIOTECH / ACON LABORATORIES, INC. COV1105014
    304411 FLOWFLEX SARS-COV-2 ANTIGEN RAPID TEST (SELF-TESTING) CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACON BIOTECH / ACON LABORATORIES, INC. COV1105014
    304412 FLOWFLEX SARS-COV-2 ANTIGEN RAPID TEST (SELF-TESTING) CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACON BIOTECH / ACON LABORATORIES, INC. COV1105014

    Patients

    Seq Age Sex Outcome Treatment
    1 Female