BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-HBS REAGENT KIT

    MDR report key: 25092196 · Received May 6, 2026

    Report

    Report Number
    3008344661-2026-00071
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    April 29, 2026
    Report Date
    May 6, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740159900
    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.ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.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, WITH PMA NUMBER P050051.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE POSITIVE ALINITY I ANTI-HBS RESULT FOR ONE SAMPLE. THE FOLLOWING RESULTS WERE PROVIDED: (REFERENCE RANGE: <10 MIU/ML) RESULT = 635 MIU/ML, ELISA = NEGATIVE, YHLO PLATFORM = POSITIVE ADDITIONAL INFORMATION PROVIDED: SURFACE ANTIGEN, E ANTIBODY, AND CORE ANTIBODY ALL POSITIVE (NO SPECIFIC RESULTS PROVIDED). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447698 ALINITY I ANTI-HBS REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 73442FZ01 00380740159900

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY I PROCESSING MODU, 03R65-01, (B)(6)