BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HBSAG NEXT QUALITATIVE REAGENT KIT

    MDR report key: 25318037 · Received May 28, 2026

    Report

    Report Number
    3008344661-2026-00079
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    January 1, 2025
    Report Date
    May 28, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740160586
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 01R64-22, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 1R64-21 / 31, WITH 510K/PMA/BLA NUMBER P210003. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    A LITERATURE STUDY BY DASDEMIR FO ET AL.,¿COMPARATIVE EVALUATION OF A NEW-GENERATION HBSAG ASSAY VERSUS A CONVENTIONAL METHOD IN OCCULT HBV INFECTION AND LOW-LEVEL HBSAG POSITIVITY,¿ MIKROBIYOLOJI BULTENI 2026;60(2):177¿187, EVALUATED THE DIAGNOSTIC PERFORMANCE OF THE ABBOTT ARCHITECT HBSAG QUALITATIVE II ASSAY COMPARED WITH A NEXT-GENERATION ASSAY (ALINITY I HBSAG NEXT QUALITATIVE) IN DETECTING HEPATITIS B INFECTION. THE STUDY REPORTED FALSE NONREACTIVE ALINITY I HBSAG NEXT QUALITATIVE RESULTS FOR 87 OCCULT HEPATITIS B INFECTION (OBI) CASES, WHERE ALL THE SAMPLES WERE CONFIRMED HBV DNA POSITIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576473 ALINITY I HBSAG NEXT QUALITATIVE REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 00380740160586

    Patients

    Seq Age Sex Outcome Treatment
    1