BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARITY DIAGNOSTICS LLC, CLARITY STREP A RAPID TEST STRIP

    MDR report key: 22379199 · Received July 1, 2025

    Report

    Report Number
    3007606081-2025-00003
    Event Type
    Malfunction
    Date Received
    July 1, 2025
    Date of Event
    February 2, 2024
    Report Date
    July 1, 2025
    Manufacturer
    GUANGZHOU WONDFO BIOTECH CO., LTD,
    Product Code
    GTY
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    DEVICE WAS DISTRIBUTED THROUGH UNINTENDED CHANNELS TO END USERS NOT AUTHORIZED OR TRAINED TO USE THE PRODUCT - THE PRODUCT IS LABELED FOR PRESCRIPTION USE ONLY. ALTHOUGH NO ADVERSE EVENTS HAVE BEEN REPORTED, THIS MISDISTRIBUTION MAY PRESENT A RISK OF USE ERROR OR MISUSE. UPON BEING CONTACTED BY THE FDA ON 02 FEB 2024, IT WAS DECIDED BY (B)(4) THAT A CORRECTIONS AND REMOVAL REPORT NEEDED TO BE FILED, THIS REPORT# (B)(4) WAS FILED ON 19-APR-2024 TO REMOVE AFFECTED UNITS FROM THE MARKET. THIS MDR IS BEING SUBMITTED RETROSPECTIVELY FOLLOWING INTERNAL AUDIT REVIEW AND IN ALIGNMENT WITH POSTMARKET SURVEILLANCE AND FDA REPORTING OBLIGATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1297241 CLARITY DIAGNOSTICS LLC, CLARITY STREP A RAPID TEST STRIP RAPID ANTIGEN TEST FOR GROUP A STREPTOCOCCUS GTY GUANGZHOU WONDFO BIOTECH CO., LTD,

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown