BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ANTI-HBC II

    MDR report key: 23336415 · Received October 20, 2025

    Report

    Report Number
    3002809144-2025-00331
    Event Type
    Malfunction
    Date Received
    October 20, 2025
    Date of Event
    September 30, 2025
    Report Date
    October 31, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    LOM
    UDI-DI
    00380740162634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER IS NO LONGER QUESTIONING THE NONREACTIVE RESULTS. THE US LIST NUMBER 06L22 IS A DIAGNOSTIC ASSAY, NOT INTENDED FOR USE IN SCREENING BLOOD, PLASMA, OR TISSUE DONORS, THEREFORE, THIS EVENT DOES NOT MEET REPORTING CRITERIA IN THE US. BASED UPON THIS NEW INFORMATION PROVIDED, THIS COMPLAINT IS NO LONGER A REPORTABLE EVENT AND NO ADDITIONAL INFORMATION WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8L44 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 6L22, WITH 510K/PMA/BLA NUMBER P080023.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE NONREACTIVE ARCHITECT ANTI-HBC II FOR ONE MALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE OF <1 S/CO): (B)(6) 2025, INITIAL ANTI-HBC RESULT= 0.1 S/CO; (B)(6) 2025, REPEAT RESULT= 7.4 S/CO AND 7.01 S/CO; REPEAT RESULT ON ANOTHER ANALYZER= 6.61 S/CO. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE NONREACTIVE ARCHITECT ANTI-HBC II FOR ONE MALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE OF <1 S/CO): ON (B)(6) 2025, INITIAL ANTI-HBC RESULT= 0.1 S/CO; (B)(6) 2025, REPEAT RESULT= 7.4 S/CO AND 7.01 S/CO; REPEAT RESULT ON ANOTHER ANALYZER= 6.61 S/CO. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2230209 ARCHITECT ANTI-HBC II TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT GMBH 70154BE01 00380740162634

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male