BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVID-19 AG HOME TEST

    MDR report key: 18096640 · Received November 7, 2023

    Report

    Report Number
    MW5147935
    Event Type
    Malfunction
    Date Received
    November 7, 2023
    Date of Event
    November 1, 2023
    Report Date
    November 1, 2023
    Manufacturer
    CELLTRION USA INC. / HUMASIS CO., LTD.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ORDERED THE FREE COVID HOME TEST KITS FROM COVIDTESTS.GOV WHICH WERE DELIVERED TODAY. THE TWO BOXES BOTH HAS EXPIRATION DATES OF 01-20-2023. KITS CAME WITH A POSTCARD WHICH EXPLAINS TO CHECK FDA'S WEBSITE FOR UPDATES IN CASES WHERE THE TESTS ARE EXPIRED AND ARE EXTENDED. THE NEW EXPIRATION DATE ON THE LINK SHOW AS 01/20/2024? WHY SEND OUT KITS THAT WILL EXPIRED IN ABOUT 2-1/2 MONTHS? IT'S WASTING THE MANPOWER AND EXPENSE OF SENDING THE OLD KITS FOR COUPLE MONTHS. SHOULD SEND OUT ONLY THE KITS THAT HAS AT LEAST SEVERAL MONTHS. OUR NEIGHBORS RECEIVED THEIR KITS AND IT WAS FOR OVER A YEAR BEFORE EXPIRATION. KITS IN QUESTION ARE MADE BY CELLTRION DIATRUST #COVSC2005HC. REF REPORT: MW5147934.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73397 COVID-19 AG HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP CELLTRION USA INC. / HUMASIS CO., LTD. COVSC2005HC

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male