BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG QUALITATIVE II

    MDR report key: 24741479 · Received March 31, 2026

    Report

    Report Number
    3008344661-2026-00062
    Event Type
    Malfunction
    Date Received
    March 31, 2026
    Date of Event
    March 15, 2026
    Report Date
    May 22, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740002435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UG
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 02G22 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 04P53, HBSAG, WITH PMA NUMBER P110029.

    Description of Event or Problem · 0

    A CONFERENCE ABSTRACT BY AYIKOBUA ACANA, S.E., ET AL. ¿HEPATITIS B CORE ANTIBODY TESTING AMONG BLOOD DONORS IN UGANDA¿ VOX SANGUINIS. 2025; 120333-334, DOCUMENTED FALSE NONREACTIVE HBSAG ON THE ARCHITECT I2000SR PROCESSING MODULE. A STUDY INCLUDING 453 ROUTINE BLOOD DONORS WAS COLLECTED BETWEEN SEPTEMBER 2024 TO DECEMBER 2024. OF THE 453 SAMPLES, 6 SAMPLES WERE FOUND TO BE NONREACTIVE FOR HBSAG AND REACTIVE ON THE NAT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443770 ARCHITECT HBSAG QUALITATIVE II TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION UNKNOWN 00380740002435

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I2000SR INST, 03M74-02, 116UNKNOWN11