BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON WHOLE BLOOD MICROCOAGULATION SYSTEM - ACT-LR CUVETTES

    MDR report key: 23469452 · Received November 4, 2025

    Report

    Report Number
    0002250033-2025-00003
    Event Type
    Malfunction
    Date Received
    November 4, 2025
    Date of Event
    October 14, 2025
    Report Date
    November 4, 2025
    Manufacturer
    ACCRIVA DIAGNOSTICS, INC.
    Product Code
    JBP
    UDI-DI
    10711234103081
    PMA / PMN Number
    K960749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE RETURNED TEST CUVETTES FROM THE CUSTOMER SHOWED NO OTHER FOREIGN OBJECTS WERE FOUND. ACCRIVA DIAGNOSTICS HAS INITIATED A RECALL PER 21 CFR 806. ACCRIVA HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A, FIELDS FOR WHICH DATA WERE NOT OBTAINABLE OR ARE NOT APPLICABLE ARE INTENTIONALLY LEFT BLANK: A2-A6, B2, B6-B7, D6-D7, D10, F1-F14, G5, H2, H9-H10.

    Description of Event or Problem · 0

    ACCRIVA DIAGNOSTICS, INC. HAS IDENTIFIED THAT AN INADVERTENT FOREIGN OBJECT WAS INCLUDED IN AT LEAST ONE (1) SEALED POUCH OF HEMOCHRON ACTIVATED CLOTTING TIME LOW-RANGE (ACT-LR) TEST CUVETTES, LOT NUMBER E5JLR132. THE FOREIGN OBJECT HAS SHARP EDGES AND COULD POSE A RISK OF INJURY FOR USERS HANDLING THE PRODUCT IF THIS ISSUE WERE TO RE-OCCUR. CURRENTLY, THERE IS NO INDICATION THAT ANY OTHER LOTS OF HEMOCHRON TEST CUVETTES ARE IMPACTED BY THIS ISSUE. TO DATE, NO ADVERSE EVENTS OR INJURIES HAVE BEEN REPORTED, AND ONLY A SINGLE CUSTOMER COMPLAINT REGARDING THIS ISSUE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255633 HEMOCHRON WHOLE BLOOD MICROCOAGULATION SYSTEM - ACT-LR CUVETTES HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT JBP ACCRIVA DIAGNOSTICS, INC. JACT-LR E5JLR132 10711234103081

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown