BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENABIO COVID-19 RAPID SELF-TEST

    MDR report key: 18828207 · Received March 4, 2024

    Report

    Report Number
    MW5152280
    Event Type
    Malfunction
    Date Received
    March 4, 2024
    Date of Event
    February 28, 2024
    Report Date
    February 29, 2024
    Manufacturer
    GENABIO DIAGNOSTICS INC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    GOVERNMENT SUPPLIED GENABIO COVID TESTS DEFECTIVE; 3 TESTS RUN FROM 3 DIFFERENT PACKAGES, NO CONTROL REACTION SEEN. STRONG POSITIVE INDICATED IN THE TEST AREA, NONE IN THE CONTROL. SUGGESTS MANUFACTURING PROBLEM. CONTROL REACTIVITY NOT DEMONSTRATED - 3 DIFFERENT TEST KITS - LOT NUMBER US220911, EXPIRATION 3/07/2024. REFERENCE REPORT #MW5152281, #MW5152282.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696639 GENABIO COVID-19 RAPID SELF-TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP GENABIO DIAGNOSTICS INC. US220911

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female DAILY MULTIVITAMIN