BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG

    MDR report key: 24413319 · Received February 23, 2026

    Report

    Report Number
    3008344661-2026-00039
    Event Type
    Malfunction
    Date Received
    February 23, 2026
    Date of Event
    February 11, 2026
    Report Date
    April 30, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740167745
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ARCHITECT HBSAG REAGENT, LOT 77409FZ01. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WAS REVIEWED. REVIEW OF TRACKING AND TRENDING BY LIST NUMBER AND BY COMPLAINT LOT DID NOT IDENTIFY ANY TRENDS. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT NUMBER AND ISSUE. CLINICAL SENSITIVITY TESTING WAS PERFORMED USING AN IN-HOUSE RETAINED KIT OF LOT 77412FZ01 WHICH CONTAINS THE SAME BULK SOLUTION AS THE COMPLAINT LOT. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSED THE ISSUE. THIS COULD POTENTIALLY BE A CASE OF OCCULT HBV INFECTION WHICH IS A KNOWN PHENOMENON AND IS DIAGNOSED WHEN A HBV DNA TEST IS POSITIVE BUT HBSAG IS UNDETECTED. OCCULT INFECTION MAY REPRESENT ACUTE INFECTION IN THE WINDOW PERIOD, HBV TAILEND OF CHRONIC HBV INFECTION, PERSISTENCE OF REPLICATION AT LOW LEVEL AFTER RECOVERY IN THE PRESENCE OF ANTI-HBS OR OCCURRENCE OF AN ESCAPE MUTANT IN VACCINATED OR UNVACCINATED INDIVIDUALS NOT DETECTED BY CURRENT HBSAG ASSAYS. (1, 2) BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ARCHITECT HBSAG REAGENT LOT 77409FZ01 WAS IDENTIFIED. 1. H. W. REESINK ET AL. OCCULT HEPATITIS B INFECTION IN BLOOD DONORS. VOX SANGUINIS (2008) 94 , 153¿1662. MICHAEL TORBENSON AND DAVID L THOMAS. OCCULT HEPATITIS B. LANCET INFECT DIS 2002; 2: 479¿86.

    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 6C36 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4P53, PMA P110029. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE NEGATIVE ARCHITECT HBSAG RESULT GENERATED ON AN ARCHITECT I2000SR ANALYZER FOR ONE PATIENT. THE INITIAL RESULT = 0.00 IU/ML (REFERENCE RANGE <0.05 IU/ML). THE PATIENT WAS SIMULTANEOUSLY TESTED FOR HBV DNA AND RECEIVED A POSITIVE RESULT WITH THE NUMBER OF COPIES BEING 4.333E+05. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE NEGATIVE ARCHITECT HBSAG RESULT GENERATED ON AN ARCHITECT I2000SR ANALYZER FOR ONE PATIENT. THE INITIAL RESULT = 0.00 IU/ML (REFERENCE RANGE <0.05 IU/ML). THE PATIENT WAS SIMULTANEOUSLY TESTED FOR HBV DNA AND RECEIVED A POSITIVE RESULT WITH THE NUMBER OF COPIES BEING 4.333E+05. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347034 ARCHITECT HBSAG TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 77409FZ01 00380740167745

    Patients

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