BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-HBS REAGENT KIT

    MDR report key: 25186449 · Received May 15, 2026

    Report

    Report Number
    3008344661-2026-00072
    Event Type
    Malfunction
    Date Received
    May 15, 2026
    Date of Event
    April 25, 2026
    Report Date
    May 15, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740159894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 07P89, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07P88 (ANTI-HBS), AND A PMA NUMBER OF P050051.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I ANTI-HBS RESULTS FOR A 55-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6), ON (B)(6) 2026, INITIAL ANTI-HBS RESULT WAS 13.52, REPEAT RESULT WAS 13.41 MIU/ML. THE PATIENT WAS RETESTED ON 11MAY AND THE ANTI-HBS RESULT WAS 13.69 MIU/ML. THE SAMPLE WAS ALSO TESTED WITH A ROCHE ASSAY, THE ANTI-HBS RESULT WAS 53.6 IU/L. THE HBV-DNA RESULT WAS <1.00E2 IU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27544 ALINITY I ANTI-HBS REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 81600FZ01 00380740159894

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female ALNTY I PROCESSING MODU, 03R65-01, (B)(6)