BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I HEALTH COVID TEST KIT

    MDR report key: 15320591 · Received August 29, 2022

    Report

    Report Number
    MW5111761
    Event Type
    Malfunction
    Date Received
    August 29, 2022
    Date of Event
    August 23, 2022
    Report Date
    August 25, 2022
    Manufacturer
    I HEALTH LABS., INC. / ANDON MEDICAL 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 COVID TEST KITS THROUGH THE UNITED STATES POSTAL SERVICE ON (B)(6) 2022. RECEIVED KITS (2 DIFFERENT KITS WITH 2 TESTS EACH) IN THE MAIL ON (B)(6) 2022. ALL THE TEST KITS DELIVERED TO ME, BY THE USPS WERE EXPIRED. IS IT LEGAL TO DISTRIBUTE EXPIRED COVID TEST KITS? WILL THEY WORK? THEY WERE ALSO DELIVERED IN 100 + DEG. TEMPS. IS THERE ANY TEMPERATURE REGULATION FOR THESE KITS? I HEALTH COVID 19, ANTIGEN RAPID TEST LOT # 221C020214 BEST BY 8/13/2022 AND LOT # 221C020121 BEST BY 7/20/2022. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385615 I HEALTH COVID TEST KIT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP I HEALTH LABS., INC. / ANDON MEDICAL CO., LTD. IC03000 (?) 221C020214
    385616 I HEALTH COVID TEST KIT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP I HEALTH LABS., INC. / ANDON MEDICAL CO., LTD. IC03000 (?) 221C02012

    Patients

    Seq Age Sex Outcome Treatment
    1 Female