BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-HBC II REAGENT KIT

    MDR report key: 24968872 · Received April 23, 2026

    Report

    Report Number
    3002809144-2026-00104
    Event Type
    Malfunction
    Date Received
    April 23, 2026
    Date of Event
    April 11, 2026
    Report Date
    April 23, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    LOM
    UDI-DI
    00380740162580
    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 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 NONREACTIVE ALINITY I ANTI-HBC II RESULTS GENERATED ON THE ALINITY I PROCESSING MODULE FOR TWO PATIENTS THAT HAD A HISTORY OF REACTIVE ANTI-HBC RESULTS. THE FOLLOWING DATA WAS PROVIDED: SAMPLE 1: SID (B)(6) (FEMALE, 41 YEARS OLD) RESULTS ON (B)(6) 2026 ON ALINITY I PLATFORM: HBCAB: 0.09/0.07/0.07 (NEGATIVE)- QUESTIONABLE RESULT OTHER TESTING PROVIDED: HBSAG: 0.00 (NEGATIVE) HBSAB: 12.07 (POSITIVE) HBEAG: 0.33 (NEGATIVE) HBEAB: 1.57 (NEGATIVE) . PREVIOUS RESULTS GENERATED ON OCTOBER 10,2025 ON ALINITY I PLATFORM: HBCAB: 1.62 (POSITIVE) OTHER TESTING PROVIDED: HBSAG: 0.01 (NEGATIVE) HBSAB: 91.24 (POSITIVE) HBEAG: 0.34 (NEGATIVE) HBEAB: 1.34 (NEGATIVE) AUTOBIO RESULT = NEGATIVE JOHNSON & JOHNSON RESULT = NEGATIVE SAMPLE 2: SID (B)(6) (MALE, 78 YEARS OLD) ALINITY I PLATFORM RESULTS ON (B)(6) 2026: HBCAB: 0.67/0.60/0.65 (NEGATIVE) ¿ QUESTIONABLE RESULT OTHER TESTING PROVIDED: HBSAG: 0.00 (NEGATIVE) 0.00 (NEGATIVE) HBSAB: 84.99 (POSITIVE) 133.27 (POSITIVE) HBEAG: 0.47 (NEGATIVE) 0.46 (NEGATIVE) HBEAB: 1.06 (NEGATIVE) 0.91 (POSITIVE). ALINITY I PLATFORM ON (B)(6) 2025: HBCAB: 1.71 (POSITIVE) OTHER TESTING PROVIDED: HBSAG: 0.00 (NEGATIVE) HBSAB: 133.27 (POSITIVE) HBEAG: 0.46 (NEGATIVE) HBEAB: 0.91 (POSITIVE. AUTOBIO RESULT = POSITIVE JOHNSON & JOHNSON RESULT = NEGATIVE . THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382101 ALINITY I ANTI-HBC II REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT GMBH 80145BE01 00380740162580

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY I PR MOD CN, 03R65-20, (B)(6)