BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-HBC II REAGENT KIT

    MDR report key: 25331348 · Received May 29, 2026

    Report

    Report Number
    3002809144-2026-00140
    Event Type
    Malfunction
    Date Received
    May 29, 2026
    Date of Event
    May 11, 2026
    Report Date
    May 29, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    LOM
    UDI-DI
    00380740130039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 7P87 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P84, WITH 510K/PMA/BLA NUMBER P080023.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE NON-REACTIVE ALINITY I ANTI-HBC II. THE CUSTOMER FURTHER COMMUNICATED THAT MULTIPLE PATIENTS HAD A POSITIVE VIRAL LOAD AND WERE REACTIVE FOR HBSAG. THE CUSTOMER PROVIDED THE FOLLOWING DATA FOR (B)(6) 2026: SAMPLE ID (B)(6) HBSAG RESULT WAS 3.1. SAMPLE ID (B)(6) HBSAG RESULT WAS 1.1. SAMPLE ID (B)(6) HBSAG RESULT WAS 88. SAMPLE ID (B)(6) HBSAG RESULT WAS 75. SAMPLE ID (B)(6) HBSAG RESULT WAS 8. SAMPLE ID (B)(6) HBSAG RESULT WAS 128. SAMPLE ID (B)(6) HBSAG RESULT WAS 5.18. PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22187 ALINITY I ANTI-HBC II REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT GMBH 83173BE00 00380740130039

    Patients

    Seq Age Sex Outcome Treatment
    1