BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HBSAG REAGENT KIT

    MDR report key: 24604101 · Received March 16, 2026

    Report

    Report Number
    3008344661-2026-00056
    Event Type
    Malfunction
    Date Received
    March 16, 2026
    Date of Event
    March 6, 2026
    Report Date
    May 1, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740160104
    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 08P08 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 04P53, ARCHITECT HBSAG, WITH PMA NUMBER P110029.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE NONREACTIVE ALINITY I HBSAG RESULTS WERE GENERATED ON A PATIENT. THE RESULTS PROVIDED WERE: INITIAL=0.00 IU/ML (< 0.05 IU/ML=NONREACTIVE) /HBV DNA=POSITIVE THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24062 ALINITY I HBSAG REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 75091FZ01 00380740160104

    Patients

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