BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENTS

    MDR report key: 23881349 · Received December 23, 2025

    Report

    Report Number
    MW5181095
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    December 17, 2025
    Report Date
    December 17, 2025
    Manufacturer
    RANDOX LABORATORIES LIMITED
    Product Code
    DHR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    RANDOX LABORATORIES ARE SELLING PRODUCTS FOR DIAGNOSTICS WITH REAGENTS ARE BEING TRANSPORTED IN THE HEAT WITHOUT ANY TEMPERATURE CONTROL. THEY RECEIVE THE PRODUCTS FROM UK WITHOUT ANY ICE PACKS AND THE PRODUCTS MIGHT LOSE POTENCY AND AFFECT PATIENTS RESULTS. THEY PROVIDE SO MANY TYPES OF TESTING FOR HORMONE TESTING AND QUALITY CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1647318 REAGENTS SYSTEM, TEST, RHEUMATOID FACTOR DHR RANDOX LABORATORIES LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other