BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RANDOX LIPOPROTEIN (A) - IN VITRO DIAGNOSTIC (IVD) USE AS RANDOX LIPOPROTEIN (A)

    MDR report key: 22161063 · Received June 6, 2025

    Report

    Report Number
    MW5171150
    Event Type
    Malfunction
    Date Received
    June 6, 2025
    Report Date
    May 30, 2025
    Manufacturer
    RANDOX LABORATORIES LIMITED
    Product Code
    DFC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    RANDOX DID NOT INFORM MY LABORATORY OF THIS RECALL EVENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265253 RANDOX LIPOPROTEIN (A) - IN VITRO DIAGNOSTIC (IVD) USE AS RANDOX LIPOPROTEIN (A) LIPOPROTEIN, LOW-DENSITY, ANTIGEN, ANTISERUM, CONTROL DFC RANDOX LABORATORIES LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown