BEUDAMED
    FDA Adverse Event No answer provided Summary report: N

    CELLTRION DIATRUST COVID-19 AGHOMETEST

    MDR report key: 15216936 · Received August 12, 2022

    Report

    Report Number
    3008719759-2022-00100
    Event Type
    No answer provided
    Date Received
    August 12, 2022
    Report Date
    August 12, 2022
    Manufacturer
    HUMASIS CO., LTD.
    Product Code
    QKP
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) AN AMAZON CUSTOMER COMMENTED THAT THE PRODUCT WAS INACCURATE.: CUSTOMER PERFORMED BOTH TESTS DAYS APART. THE LAST TEST WAS DONE WITH DIFFERENT BRANDS IN THE MORNING AND IN THE AFTERNOON, AND IT WAS CLEARLY POSITIVE. IMPORTER COMMENTS: DUE TO THE SYSTEM FUNCTIONALITY TO NOT ALLOW SELLER CAN LEAVE THE COMMENTS ON THE WEBSITE OR CONTACT THE REPORTER, IT IS NOT ABLE FOR US TO FOLLOW UP TO COLLECT ADDITIONAL INFORMATION, SUCH AS PRODUCT INFORMATION (LOT #, EXPIRATION DATE, ETC.) AND ANY EVIDENCE OF PCR RESULT TO PROVE FALSE RESULT ETC FOLLOWING BY REPORTER'S CONSENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1929988 CELLTRION DIATRUST COVID-19 AGHOMETEST IN VITRO DIAGNOSTICS QKP HUMASIS CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown