BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ANTI-HBS

    MDR report key: 24016555 · Received January 8, 2026

    Report

    Report Number
    3008344661-2026-00004
    Event Type
    Malfunction
    Date Received
    January 8, 2026
    Date of Event
    December 30, 2025
    Report Date
    February 4, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740159948
    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 BELIEVED THE RESULTS FROM THE ARCHITECT PLATFORM WERE ABNORMAL WHEN THEY INITIALLY REPORTED THE EVENT. NOW THE CUSTOMER IS NOT QUESTIONING THE RESULTS AND THAT BELIEVES THAT THEY ARE CORRECT. BASED UPON THIS NEW INFORMATION, THIS COMPLAINT IS NO LONGER A REPORTABLE EVENT.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07C18-74 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 1L82, WITH 510K/PMA/BLA NUMBER P050051.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE ELEVATED ARCHITECT ANTI-HBS AND PROVIDED THE FOLLOWING DATA: ANTI-HBS RESULT WAS 75.63 MIU/ML AND REPEAT RESULT WAS 77.24 MIU/ML BASED ON THE WORLD HEALTH ORGANIZATION RECOMMENDATION, AN ANTI-HBS CONCENTRATION = 10 MIU/ML IS REGARDED AS BEING PROTECTIVE AGAINST HEPATITIS B VIRAL INFECTION. PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE ELEVATED ARCHITECT ANTI-HBS AND PROVIDED THE FOLLOWING DATA: ANTI-HBS RESULT WAS 75.63 MIU/ML AND REPEAT RESULT WAS 77.24 MIU/ML. BASED ON THE WORLD HEALTH ORGANIZATION RECOMMENDATION, AN ANTI-HBS CONCENTRATION = 10 MIU/ML IS REGARDED AS BEING PROTECTIVE AGAINST HEPATITIS B VIRAL INFECTION. PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77927 ARCHITECT ANTI-HBS TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 79006FZ01 00380740159948

    Patients

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