BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IHEALTH COVID-19 TEST

    MDR report key: 16195172 · Received January 17, 2023

    Report

    Report Number
    MW5114354
    Event Type
    Malfunction
    Date Received
    January 17, 2023
    Date of Event
    January 8, 2023
    Report Date
    January 15, 2023
    Manufacturer
    IHEALTH LABS, INC. /IHEALTH MANUFACTURING INC.
    Product Code
    QKP
    UDI-DI
    20856362005894
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAD ORDERED COVID TESTS FROM THE USPS A NUMBER OF MONTHS BACK. I RECEIVED THE IHEALTH BRANDED COVID TESTS. THIS DAY, I TRIED TO USE THEM, AND 4 IHEALTH TEST IN A ROW WERE INVALID. THEY HAD VERY FAINT CONTROL LINES, AND A COUPLE WERE NONEXISTENT. I HAD TO TAKE 5 COVID TESTS BEFORE I GOT ONE THAT WAS A VALID TEST. I NOTICED THAT ALL OF THE INVALID TESTS CAME FROM THE SAME LOT AND HAD THE SAME EXPIRATION DATE. THE LOT IS 213C021228 AND THE EXPIRATION DATE WAS 2022-06-27. NOTE THAT AT THE TIME I TOOK THE COVID TESTS IN (B)(6) 2023, THESE IHEALTH TESTS HAD AN AUTHORIZED FDA EXTENSION OF THEIR EXPIRATION DATE BY 6 MONTHS, SO THESE TESTS WERE NOT EXPIRED. PLEASE NOTE, I FOUND A RECALL FOR IHEALTH COVID TESTS FOR A VERY SIMILAR PROBLEM, BUT THE AFFECTED LOT NUMBERS AND EXPIRATION DATES DID NOT MATCH MY BOX: HTTPS://SCDHEC.GOV/NEWS-RELEASES/RESIDENTS-URGED-DISCARD-INVALID-IHEALTH-COVID-19-RAPID-ANTIGEN-HOME-TESTKITS-0. I HAD 4 OF THESE EXACT SAME TESTS IN A ROW THAT WERE INVALID. NOTE THAT THE PHOTOS EXACERBATE HOW DARK THE LINE WAS, THEY ARE BARELY VISIBLE. THESE ARE ALSO PICTURES OF THE TESTS THE NEXT DAY, FAR OUTSIDE OF THE TEST WINDOW OF 15-30 MINUTES, SO THEY LOOK DARKER IN THE PICTURE THAN THEY WERE DURING THE VALID READING TIME OF THE TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129469 IHEALTH COVID-19 TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP IHEALTH LABS, INC. /IHEALTH MANUFACTURING INC. ICO-3000 213CO21228 20856362005894
    129470 IHEALTH COVID-19 TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP IHEALTH LABS, INC. /IHEALTH MANUFACTURING INC. ICO-3000 213CO21228 20856362005894
    129471 IHEALTH COVID-19 TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP IHEALTH LABS, INC. /IHEALTH MANUFACTURING INC. ICO-3000 213CO21228 20856362005894
    129472 IHEALTH COVID-19 TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP IHEALTH LABS, INC. /IHEALTH MANUFACTURING INC. ICO-3000 213CO21228 20856362005894

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male Other