BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG

    MDR report key: 24443093 · Received February 25, 2026

    Report

    Report Number
    3008344661-2026-00043
    Event Type
    Malfunction
    Date Received
    February 25, 2026
    Date of Event
    May 1, 2022
    Report Date
    April 29, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740115678
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 6C36 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4P53, WITH 510K/PMA/BLA NUMBER P110029.

    Description of Event or Problem · 0

    AN ARTICLE BY LEONIE BADOT, ET.AL., ¿COMPARATIVE PERFORMANCE OF THE SIEMENS ATELLICA AND ABBOTT ARCHITECT ASSAYS FOR HBSAG QUANTIFICATION IN PATIENTS WITH CHRONIC HEPATITIS B OR HEPATITIS DELTA JOURNAL OF CLINICAL VIROLOGY: THE OFFICIAL PUBLICATION OF THE PAN AMERICAN SOCIETY FOR CLINICAL VIROLOGY. 2026; 182105913. DOI: 10.1016/J.JCV.2026.105913., DOCUMENTS NEGATIVE ARCHITECT HBSAG RESULTS THAT WERE POSITIVE WITH SIEMENS ATELLICA. FROM MAY TO NOVEMBER OF 2022, A TOTAL OF 311 SERUM SAMPLES FROM 216 PATIENTS WERE COLLECTED AND ANALYZED USING QHBSAG ATELLICA AND ARCHITECT ASSAYS. THE STUDY NOTED TWO SAMPLES WERE NOT DETECTED BY THE ARCHITECT ASSAY (<0.05 IU/ML), WHEREAS THE ATELLICA ASSAY DETECTED THESE LOW QHBSAG VALUES (0.06 AND 0.07 IU/ML). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165639 ARCHITECT HBSAG TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 00380740115678

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I1000SR MOD, 01L86-01, 117UNKNOWND11| ARC I1000SR MOD, 01L86-01, 117UNKNOWND11