BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELL ME FAST NOVEL CORONAVIRUS (COVID-19) IGG/IGM AB TEST CASSETTE B251C

    MDR report key: 10137613 · Received June 9, 2020

    Report

    Report Number
    MW5094905
    Event Type
    Malfunction
    Date Received
    June 9, 2020
    Date of Event
    May 23, 2020
    Report Date
    June 6, 2020
    Manufacturer
    BIOCAN DIAGNOSTICS INC.
    Product Code
    QKO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RECEIVED NO RESULT ON AN ANTIBODY TEST THAT IS ADVERTISING ITSELF AS FDA APPROVED. SEEMS TO BE FAKE, MADE IN (B)(6) BUT DISGUISING ITSELF AS MADE IN (B)(6). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595666 TELL ME FAST NOVEL CORONAVIRUS (COVID-19) IGG/IGM AB TEST CASSETTE B251C REAGENT, CORONAVIRUS SEROLOGICAL QKO BIOCAN DIAGNOSTICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR