BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE® TUBE 8 ML CAT SERUM SEP CLOT ACTIVATOR, VACUETTE® TUBE 5 ML CAT SERUM

    MDR report key: 25232250 · Received May 20, 2026

    Report

    Report Number
    1125230-2026-00015
    Event Type
    Malfunction
    Date Received
    May 20, 2026
    Report Date
    May 20, 2026
    Manufacturer
    GREINER BIO-ONE NORTH AMERICA INC.
    Product Code
    JKA
    PMA / PMN Number
    K960858
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT (B)(4): SAMPLES HAVE BEEN RECEIVED AND ARE BEING EVALUATED AS PART OF THE COMPLAINT INVESTIGATION. UPON COMPLETION OF THE COMPLAINT INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THEY EXPERIENCED SAMPLES WITH INCREASED POTASSIUM RESULTS WITH 2 LOTS OVER A PERIOD OF 1-2 MONTHS. TEN SPECIMENS REPORTED AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556962 VACUETTE® TUBE 8 ML CAT SERUM SEP CLOT ACTIVATOR, VACUETTE® TUBE 5 ML CAT SERUM EVACUATED BLOOD COLLECTION TUBES JKA GREINER BIO-ONE NORTH AMERICA INC. 455071P, 456018P B2511346, B2601355

    Patients

    Seq Age Sex Outcome Treatment
    1