BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY

    MDR report key: 23390779 · Received October 27, 2025

    Report

    Report Number
    3008344661-2025-00148
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Date of Event
    July 28, 2025
    Report Date
    December 19, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740002466
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER: 2G23 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER: 4P54, WITH 510K/PMA/BLA NUMBER: P110029.

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF COMPLAINT DATA FOR THE PRODUCT AND LIKELY CAUSE IDENTIFIED NORMAL COMPLAINT ACTIVITY. REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR THE REAGENT LOT. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LOT DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. THE PERFORMANCE OF THE LIKELY CAUSE LOT WAS INVESTIGATED BY COMPLETING A REVIEW FOR NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES AND DEVIATIONS RELATED TO THE LIKELY CAUSE LOT. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES, OR DEVIATIONS. TESTING COULD NOT BE CARRIED OUT ON 2G23-25 (ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY) BECAUSE THE LOT WAS UNKNOWN. ALL SPECIFICATIONS WERE MET INDICATING THAT THE ASSAY IS PERFORMING ACCEPTABLY. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY REAGENT WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE REACTIVE ARCHITECT HBSAG QUALITATIVE II RESULT ON ANTENATAL FEMALE PATIENT.: RESULTS WERE REPORTED TO MEDICAL PROVIDER. FOLLOWING DATA PROVIDED FROM ON (B)(6) 2025. SID: (B)(6); INITIAL RESULT = 2.36 S/CO (REACTIVE), REPEAT RESULTS; 2.21 AND 2.32 S/CO (REACTIVE), % NEUTRALIZATION WAS 78.7%. RESULTS FROM ANOTHER INSTRUMENT (BIO MERIEUX) VIDAS: 0.16 (REACTIVE), REFERENCE RANGE (NEGATIVE <0.10, POSITIVE =0.10). THE CUSTOMER HAS NOT PROVIDED THE C2 RESULT FROM THE CONFIRMATORY BUT BELIEVES PATIENT SID: (B)(6) IS FALSE REACTIVE WITH CONFIRMATORY TESTING. OTHER RESULTS WERE AS FOLLOWS AND CUSTOMER IS NOT QUESTIONING RESULTS FROM ANY OTHER ASSAYS. ANTI-HBCORE (TOTAL): 6.12 (REACTIVE), ANTI-HBC IGM: 2 (NON-REACTIVE), HBEAG: 0.443 / 0.399 (NON-REACTIVE), ANTI-HBE: 1.39 & 1.32 (NON-REACTIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE REACTIVE ARCHITECT HBSAG QUALITATIVE II RESULT ON ANTENATAL FEMALE PATIENT.: RESULTS WERE REPORTED TO MEDICAL PROVIDER. FOLLOWING DATA PROVIDED FROM (B)(6) 2025. SID (B)(6); INITIAL RESULT = 2.36 S/CO (REACTIVE), REPEAT RESULTS; 2.21 AND 2.32 S/CO (REACTIVE), % NEUTRALIZATION WAS 78.7%. RESULTS FROM ANOTHER INSTRUMENT (BIO MERIEUX) VIDAS: 0.16 (REACTIVE), REFERENCE RANGE (NEGATIVE <0.10, POSITIVE =0.10). THE CUSTOMER HAS NOT PROVIDED THE C2 RESULT FROM THE CONFIRMATORY BUT BELIEVES PATIENT SID: (B)(6) IS FALSE REACTIVE WITH CONFIRMATORY TESTING. OTHER RESULTS WERE AS FOLLOWS AND CUSTOMER IS NOT QUESTIONING RESULTS FROM ANY OTHER ASSAYS. ANTI-HBCORE (TOTAL): 6.12 (REACTIVE) ANTI-HBC IGM: 2 (NON-REACTIVE) HBEAG: 0.443 / 0.399 (NON-REACTIVE) ANTI-HBE: 1.39 & 1.32 (NON-REACTIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2351516 ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 00380740002466

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female ARC HBSAG QUAL II 2000T, 02G22-30, 73407FZ00.| ARC I2SR ANLYZR G-RFURB, 03M74-95, ISR01569.