BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HBSAG REAGENT KIT

    MDR report key: 25203764 · Received May 18, 2026

    Report

    Report Number
    3008344661-2026-00074
    Event Type
    Malfunction
    Date Received
    May 18, 2026
    Date of Event
    April 30, 2026
    Report Date
    May 18, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740130176
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P08 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 04P53, WITH PMA NUMBER P110029.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE NONREACTIVE ALINITY I HBSAG FOR ONE PATIENT WITH CHRONIC HEPATITIS B UNDER OBSERVATION SINCE AT LEAST BEFORE 2022. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE WAS 0-0.05 IU/ML): ALINITY RESULT PROCESSED ON (B)(6) 2026 = 0.02 REPEAT RESULTS THE SAME WITH ORIGINAL SAMPLE AND PLASMA SAMPLE LUMIPULSE (FUJIREBIO) RESULT FROM (B)(6) 2025 = 112.88 IU/ML HBV DNA PCR HISTORY: (B)(6) 2025 = 2.1 POSITIVE, (B)(6) 2025 = <1.0 NEGATIVE, (B)(6) 2026 = <1.0 NEGATIVE. SAMPLE SENT OUT TESTED ON LUMIPULSE L2400 HBSAG = 0.052 POSITIVE IU/ML (REFERENCE VALUE <0.005) THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298199 ALINITY I HBSAG REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 80101FZ00 00380740130176

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY I PROCESSING MODU, 03R65-01, AI32944.