BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDX COVID TEST KIT

    MDR report key: 18535593 · Received January 17, 2024

    Report

    Report Number
    MW5150475
    Event Type
    Malfunction
    Date Received
    January 17, 2024
    Report Date
    January 14, 2024
    Manufacturer
    CORDX, 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

    THE COVID TEST KITS PRODUCED BY CORDX ARE REPORTED TO HAVE SERIOUS QUALITY ISSUES. THEIR PRODUCTS LACK OF FDA CERTIFICATION, AND THEY DON'T EVEN HAVE A LICENSE FOR THE STATE OF (B)(6). I'M UNSURE HOW SUCH PRODUCTS ARE ALLOWED IN THE U.S. MARKET AND HOW THEY MANAGE TO SECURE GOVERNMENT ORDERS. I CONTRACTED COVID LAST WEEK AND TESTED THREE TIMES WITH CORDX'S PRODUCT, GETTING DIFFERENT RESULTS EACH TIME. THIS LED ME TO MISS THE OPTIMAL TREATMENT WINDOW. REFERENCE REPORTS MW5150474, MW5150476.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2477485 CORDX COVID TEST KIT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP CORDX, INC. 30341

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other