BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HBSAG QUALITATIVE II REAGENT KIT

    MDR report key: 24176855 · Received January 26, 2026

    Report

    Report Number
    3008344661-2026-00013
    Event Type
    Malfunction
    Date Received
    January 26, 2026
    Date of Event
    January 1, 2021
    Report Date
    March 10, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740130398
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    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. THE TICKET SEARCH BY LOT COULD NOT BE PERFORMED SINCE THE LOT NUMBERS ARE UNKNOWN. A REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I HBSAG QUALITATIVE II ASSAY DID NOT IDENTIFY ANY RELATED TRENDS. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY RELATED NONCONFORMANCES, POTENTIAL NONCONFORMANCE OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT ASSAY AND COMPLAINT ISSUE. CUSTOMER FIELD DATA WAS USED TO ASSESS THE PERFORMANCE OF THE ALINITY I HBSAG QUALITATIVE II ASSAY USING WORLDWIDE DATA. REVIEW SHOWS THAT THE MEDIAN PATIENT RESULTS FOR ALL REVIEWED LOTS ARE COMPARABLE, AND THE MAJORITY ARE WITHIN ESTABLISHED LIMITS, CONFIRMING NO SYSTEMIC ISSUE. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. THE STUDY DOCUMENTS THAT FOR THE SAMPLES INCLUDED IN THE STUDY, 112 WERE POSITIVE FOR HBSAG. 65 OF THESE SAMPLES WERE HBV DNA POSITIVE, WITH THE REMAINING 5 TESTING HBV DNA NEGATIVE. HOWEVER, THERE IS NO INDICATION IN THE PUBLICATION AS TO WHETHER THE FULL TESTING ALGORITHM WAS FOLLOWED. PER THE ALINITY I HBSAG ASSAY IFU, INITIALLY REACTIVE HBSAG RESULTS MUST BE RETESTED IN DUPLICATE. IF BOTH RETEST RESULTS ARE NONREACTIVE, THE SPECIMEN IS CONSIDERED NEGATIVE FOR HBSAG. IF ONE OR BOTH RETEST RESULTS ARE REACTIVE, THE SPECIMEN IS CONSIDERED REPEATEDLY REACTIVE FOR HBSAG. REPEAT REACTIVE RESULTS MUST BE CONFIRMED USING A NEUTRALIZING ASSAY (ALINITY I HBSAG QUALITATIVE II CONFIRMATORY ASSAY IS RECOMMENDED) BEFORE DISCLOSING HBSAG STATUS TO THE PATIENT. THE PUBLICATION DOES NOT REFER TO THE DOUBLE RETEST OR USE OF THE CONFIRMATORY NEUTRALIZING ASSAY IN THIS STUDY. PER PRODUCT LABELLING, IF THE ALINITY I HBSAG QUALITATIVE II RESULTS ARE INCONSISTENT WITH CLINICAL EVIDENCE, ADDITIONAL TESTING IS SUGGESTED TO CONFIRM THE RESULT. FOR DIAGNOSTIC PURPOSES, RESULTS SHOULD BE USED IN CONJUNCTION WITH PATIENT HISTORY AND OTHER HEPATITIS MARKERS FOR DIAGNOSIS OF ACUTE AND CHRONIC INFECTION. THE ABSENCE OF HBV DNA IN HBSAG-POSITIVE SAMPLES HAS ALSO BEEN DOCUMENTED PREVIOUSLY, AND IT IS POSSIBLE THAT HBSAG IN SERUM MAY OCCUR FROM A LOW LEVEL OF SURFACE ANTIGEN EXPRESSION STEMMING FROM DEFECTIVE VIRIONS OR OCCURRING FROM INTEGRATED HBV INDEPENDENT OF VIRAL REPLICATION (LOEB, K.R. 2000 ¿HIGH-THROUGHPUT QUANTITATIVE ANALYSIS OF HEPATITIS B VIRUS DNA IN SERUM USING THE TAQMAN FLUOROGENIC DETECTION SYSTEM¿ HEPATOLOGY VOL. 32, NO. 3, 626-629). BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I HBSAG QUALITATIVE II REAGENT WAS IDENTIFIED.

    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 8P10-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P10-21/-31, WITH 510K/PMA/BLA NUMBER P110029.

    Description of Event or Problem · 0

    AN ARTICLE BY A.A. PROTOPAPAS, ET.AL., ¿UNIVERSAL SCREENING FOR VIRAL HEPATITIS IN ALL INPATIENTS OF A UNIVERSITY INTERNAL MEDICINE DEPARTMENT¿, ANNALS OF GASTROENTEROLOGY. 2025; 38(6):676-680. DOI: 10.20524/AOG.2025.1005., DOCUMENTS PATIENTS WITH POSITIVE ALINITY I HBSAG RESULTS THAT WERE HBV DNA NEGATIVE. A TOTAL OF 3914 PATIENTS WERE INCLUDED IN THE STUDY FROM JANUARY 2021 TO SEPTEMBER 2023. 112 PATIENTS TESTED POSITIVE FOR ALINITY I HBSAG. DURING HOSPITALIZATION, HBV DNA TESTING WAS PERFORMED IN 65 OF THESE PATIENTS, WITH 60 PATIENTS HAVING DETECTABLE HBV DNA. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    AN ARTICLE BY A.A. PROTOPAPAS, ET.AL., ¿UNIVERSAL SCREENING FOR VIRAL HEPATITIS IN ALL INPATIENTS OF A UNIVERSITY INTERNAL MEDICINE DEPARTMENT¿, ANNALS OF GASTROENTEROLOGY. 2025; 38(6):676-680. DOI: 10.20524/AOG.2025.1005., DOCUMENTS PATIENTS WITH POSITIVE ALINITY I HBSAG RESULTS THAT WERE HBV DNA NEGATIVE. A TOTAL OF 3914 PATIENTS WERE INCLUDED IN THE STUDY FROM JANUARY 2021 TO SEPTEMBER 2023. 112 PATIENTS TESTED POSITIVE FOR ALINITY I HBSAG. DURING HOSPITALIZATION, HBV DNA TESTING WAS PERFORMED IN 65 OF THESE PATIENTS, WITH 60 PATIENTS HAVING DETECTABLE HBV DNA. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621641 ALINITY I HBSAG QUALITATIVE II REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 00380740130398

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY I PROCESSING MODU, 03R65-01, 205UNKNOWND11.| ALNTY I PROCESSING MODU, 03R65-01, 205UNKNOWND11.