BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AT-HOME COVID ANTIGEN TEST

    MDR report key: 21363438 · Received February 11, 2025

    Report

    Report Number
    MW5165979
    Event Type
    Malfunction
    Date Received
    February 11, 2025
    Date of Event
    February 3, 2025
    Report Date
    February 5, 2025
    Manufacturer
    OSANG HEALTHCARE CO., LTD.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WAS SHIPPED 2 BOXES OF OSANG OHC COVID AT-HOME ANTIGEN TESTS FROM FDA.GOV WHICH WERE ALREADY EXPIRED PAST THE EXTENDED DATE: OHC SHA2401-YA30-040AF: BOX EXP 1/29/2024, EXTENDED EXP 1/29/2025 (ALREADY EXPIRED). THESE SHOULD NOT HAVE BEEN SHIPPED. I NEED TO RE-ORDER, PLEASE. REFERENCE REPORT: MW5165980.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163882 AT-HOME COVID ANTIGEN TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP OSANG HEALTHCARE CO., LTD. OHC SHA2401-YA30-040AF

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male