BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALOTECH G2 KIT

    MDR report key: 10553331 · Received September 17, 2020

    Report

    Report Number
    MW5096746
    Event Type
    Malfunction
    Date Received
    September 17, 2020
    Date of Event
    September 16, 2020
    Report Date
    September 16, 2020
    Manufacturer
    HALOTECH, SRL. / HALOTECH DNA SL
    Product Code
    POV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    INCORRECT FERTILITY TMT; NOT AN INCIDENT BUT A VIOLATION: (B)(4), IS THE IMPORTER OF THE HALOTECH LINE OF SPERM TESTING KITS AND STAINS WHICH ARE WIDELY DISTRIBUTED IN THE US WITH MARKETING CLAIMS REGARDING DNA FRAGMENTATION THAT HAVE NEVER BEEN VALIDATED IN HUMAN CLINICAL TRIALS AND ARE NOT REVIEWED BY THE FDA AS A DIAGNOSTIC TEST. THE SAFETY AND EFFICACY AS WELL AS THERMAL STABILITY OF THE TESTS ARE UNKNOWN, YET THESE TESTS ARE MARKETED WIDELY TO THE IVF AND ART COMMUNITIES OF HEALTHCARE PROFESSIONALS. FALSE OR INACCURATE READINGS MAY LEAD EMBRYOLOGISTS AND ANDROLOGISTS TO PRESCRIBE A PROGRAM OF TREATMENT INAPPROPRIATE FOR COUPLES SEEKING TO ACHIEVE PREGNANCY. THE FDA IS URGED TO CEASE THE IMPORTATION OF THE HALOTECH G2 KIT AND THE SEVERAL VARIANTS NOW IMPORTED BY (B)(4). DNA FRAGMENTATION IS AN INDICATOR OF DAMAGE CAUSED BY OXIDATIVE STRESS TO SPERM. THE FDA HAS NOT REVIEWED THE HALOTECH LINE FOR ANY EFFICACY IN DIAGNOSIS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1012339 HALOTECH G2 KIT SEMEN ANALYSIS DEVICE POV HALOTECH, SRL. / HALOTECH DNA SL HT-HSG2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other