BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG

    MDR report key: 24734298 · Received March 30, 2026

    Report

    Report Number
    3008344661-2026-00061
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 15, 2026
    Report Date
    May 5, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740115678
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MK
    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 06C36 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4P53, HBSAG, WITH PMA NUMBER P110029.

    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. A SEARCH FOR SIMILAR COMPLAINTS WAS NOT PERFORMED AS THE LOT NUMBER IS UNKNOWN. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT ASSAY. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. A REVIEW OF PUBLICATIONS, H. W. REESINK ET AL. ¿OCCULT HEPATITIS B INFECTION IN BLOOD DONORS.¿ VOX SANGUINIS (2008) 94, 153-166 AND M. TORBENSON ET AL. ¿OCCULT HEPATITIS B.¿ LANCET INFECT DIS 2002; 2: 479-86, IDENTIFIED THAT AN OCCULT HBV INFECTION IS A KNOWN PHENOMENON AND IS DIAGNOSED WHEN A HBV DNA TEST IS POSITIVE BUT HBSAG IS UNDETECTED. OCCULT HBV CAN REPRESENT ACUTE INFECTION IN THE WINDOW PERIOD WHEN VIRAL DNA IS PRESENT BUT HBSAG LEVELS ARE LOW. AS WELL AS REPRESENTING INFECTION WITHIN THE WINDOW PERIOD, OCCULT INFECTION MAY ALSO REPRESENT HBV TAIL-END OF CHRONIC HBV INFECTION, PERSISTENCE OF REPLICATION AT LOW LEVEL AFTER RECOVERY OR OCCURRENCE OF AN ESCAPE MUTANT IN VACCINATED OR UNVACCINATED INDIVIDUALS NOT DETECTED BY CURRENT HBSAG ASSAYS. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT HBSAG REAGENT WAS IDENTIFIED.

    Description of Event or Problem · 0

    A CONFERENCE ABSTRACT BY MAKAROVSKA BOJADJIEVA, T., NIKOLOSKA, ET AL., ¿THE YIELD OF NUCLEIC ACID TESTING A THREE YEARS EXPERIENCE¿, VOX SANGUINIS. 2025; 120316, NOTED FALSE NEGATIVE ARCHITECT HBSAG RESULTS GENERATED ON THE ARCHITECT I2000SR WHEN COMPARED TO NUCLEIC ACID TESTING (NAT). THE STUDY STATED THAT DONOR BLOOD SAMPLES WERE SCREENED FOR THE PRESENCE OF HBV DNA USING THE PROCLEIX ULTRIOPLEX E ASSAY (PROCLEIX PANTHER SYSTEM), AS WELL AS TESTING THESE SAMPLES FOR THE PRESENCE OF HBSAG USING THE ARCHITECT I2000SR PLATFORM. THE DATA SHOWED 22 NAT ONLY POSITIVE DONOR SAMPLES, OF WHICH 21 OF THOSE SAMPLES GENERATED HBV DNA POSITIVE / HBSAG NEGATIVE RESULTS. NEW BLOOD SAMPLES WERE OBTAINED FOR 11 BLOOD DONORS FROM THE ORIGINAL 21 SAMPLES THAT TESTED NEGATIVE FOR HBSAG. 4 OF THE 21 DONORS PERSISTENTLY GENERATED NEGATIVE HBSAG RESULTS.

    Description of Event or Problem · 0

    A CONFERENCE ABSTRACT BY MAKAROVSKA BOJADJIEVA, T., NIKOLOSKA, ET AL., ¿THE YIELD OF NUCLEIC ACID TESTING A THREE YEARS EXPERIENCE¿, VOX SANGUINIS. 2025; 120316, NOTED FALSE NEGATIVE ARCHITECT HBSAG RESULTS GENERATED ON THE ARCHITECT I2000SR WHEN COMPARED TO NUCLEIC ACID TESTING (NAT). THE STUDY STATED THAT DONOR BLOOD SAMPLES WERE SCREENED FOR THE PRESENCE OF HBV DNA USING THE PROCLEIX ULTRIOPLEX E ASSAY (PROCLEIX PANTHER SYSTEM), AS WELL AS TESTING THESE SAMPLES FOR THE PRESENCE OF HBSAG USING THE ARCHITECT I2000SR PLATFORM. THE DATA SHOWED 22 NAT ONLY POSITIVE DONOR SAMPLES, OF WHICH 21 OF THOSE SAMPLES GENERATED HBV DNA POSITIVE / HBSAG NEGATIVE RESULTS. NEW BLOOD SAMPLES WERE OBTAINED FOR 11 BLOOD DONORS FROM THE ORIGINAL 21 SAMPLES THAT TESTED NEGATIVE FOR HBSAG. 4 OF THE 21 DONORS PERSISTENTLY GENERATED NEGATIVE HBSAG RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257379 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