BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-HBS REAGENT KIT

    MDR report key: 24604612 · Received March 16, 2026

    Report

    Report Number
    3008344661-2026-00057
    Event Type
    Malfunction
    Date Received
    March 16, 2026
    Date of Event
    March 6, 2026
    Report Date
    May 13, 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 FINAL 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 7P89 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P88, ANTI-HBS, WITH PMA NUMBER P050051.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I ANTI-HBS FOR ONE PATIENT. WHEN THE SAMPLES WERE REPEATED, THE RESULTS WERE HIGHER. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE >10 MIU/ML): SID (B)(6), INITIAL ANTI-HBS RESULT= 8.29 MIU/ML; REPEAT RESULT= 17.33 MIU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364586 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