BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG

    MDR report key: 23421066 · Received October 29, 2025

    Report

    Report Number
    3008344661-2025-00152
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Date of Event
    October 20, 2025
    Report Date
    January 7, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740167721
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATA AND INFORMATION PROVIDED IN THE ARTICLE WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT HBSAG ASSAY DID NOT IDENTIFY ANY TRENDS RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, NO TRENDS WERE IDENTIFIED FOR LOT 73481FZ01. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT ASSAY. IN HOUSE SENSITIVITY TESTING WAS PERFORMED USING A RETAINED KIT OF LOT 73481FZ01 STORED AT THE RECOMMENDED STORAGE CONDITION. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT HBSAG REAGENT LOT 73481FZ01 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 06C36-76 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4P53, WITH 510K/PMA/BLA NUMBER P110029.AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE NONREACTIVE ARCHITECT HBSAG RESULTS FOR ONE PATIENT. ARCHITECT HBSAG RESULT WAS 0.00 IU/ML (NONREACTIVE) HBV-DNA RESULT WAS POSITIVE AT 31.5 IU/ML (LOWER QUANTITATIVE LIMIT: 20 IU/ML). OTHER RESULTS PROVIDED: ANTI-HBS 54.97 MIU/ML, HBEAG (NEGATIVE): 0.776 S/CO, ANTI-HBE (NEGATIVE): 1.77 S/CO, ANTI-HBC (NEGATIVE): 0.15 S/CO. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE NONREACTIVE ARCHITECT HBSAG RESULTS FOR ONE PATIENT. ARCHITECT HBSAG RESULT WAS 0.00 IU/ML (NONREACTIVE) HBV-DNA RESULT WAS POSITIVE AT 31.5 IU/ML (LOWER QUANTITATIVE LIMIT: 20 IU/ML). OTHER RESULTS PROVIDED: ANTI-HBS 54.97 MIU/ML, HBEAG (NEGATIVE): 0.776 S/CO, ANTI-HBE (NEGATIVE): 1.77 S/CO, ANTI-HBC (NEGATIVE): 0.15 S/CO. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2251624 ARCHITECT HBSAG TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 73481FZ01 00380740167721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I2000SR INST, 03M74-02, (B)(6)