BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STREP A TEST KIT

    MDR report key: 18614232 · Received January 30, 2024

    Report

    Report Number
    MW5150925
    Event Type
    Malfunction
    Date Received
    January 30, 2024
    Date of Event
    January 27, 2024
    Report Date
    January 27, 2024
    Manufacturer
    WONDFO USA CO., LTD.
    Product Code
    GTY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WE PURCHASED STREP TESTS FROM WONDFO USA THROUGH (B)(6) AND ALL OF THE TEST STRIPS ARE INVALID WITH NO LINES. I'VE REACHED OUT TO THEM WITH NO LUCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420362 STREP A TEST KIT ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. GTY WONDFO USA CO., LTD. X00421WE49 W039307002

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown