BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-HBC II REAGENT KIT

    MDR report key: 24955616 · Received April 22, 2026

    Report

    Report Number
    3002809144-2026-00102
    Event Type
    Malfunction
    Date Received
    April 22, 2026
    Date of Event
    November 19, 2025
    Report Date
    May 14, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    LOM
    UDI-DI
    00380740130039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 A 68-YEAR-OLD MALE PATIENT. THE CUSTOMER STATED THIS PATIENT HAS A POSITIVE HBV DNA TEST. THE PATIENT HAS BEEN TESTED SEVERAL TIMES AND ONLY QUESTIONING THE ANTI-HBC II RESULTS. ALL THE SAMPLES PROVIDED ARE FROM THE SAME PATIENT AT DIFFERENT TIME PERIODS. THE FOLLOWING DATA WAS PROVIDED: TESTED ON (B)(6) 2025, SID (B)(6): ANTI-HBC II RESULT = 0.33 S/CO. TESTED ON (B)(6) 2026, SID (B)(6): ANTI-HBC II RESULT = 0.42 S/CO. TESTED ON (B)(6) 2026, SID (B)(6): ANTI-HBC II RESULT = 0.48 S/CO. ADDITIONAL LABORATORY DATA PROVIDED: TESTED ON (B)(6) 2025: HIV AG/AB = 0.11 S/CO, HBSAG QUA = 0.58 S/CO, ANTI-HCVII = 0.25 S/CO. TESTED ON (B)(6) 2025: ANTI-HBSDIL = 63.17 MIU/ML. HIV AG/AB = 0.16 S/CO, HBSAG QUA = 1.14 S/CO, HBSAG QUA = 1.06 S/CO, HBSAGQUAC2 = 0.89 S/CO, HBSAGQUAC1 = 0.40 S/CO, HBSAGQUA%N = 88 % NEUT. TESTED ON (B)(6) 2026: ANTI-HBE = 0.09 S/CO, ANTI-HBSDIL = 39.94 MIU/ML, HBSAG QUA = 1.25 S/CO, HBEAG = 0.637 S/CO, HAVAB-IGG = 4.11 S/CO. TESTED ON (B)(6) 2026: ANTI- HCVII = 0.20 S/CO. SID (B)(6): HBSAG QUA = 1.41 S/CO, HIV AG/AB = 0.49 S/CO, ANTIHBSDIL = 34.16 MIU/ML. TESTED ON (B)(6) 2026: HBEAG = 0.769 S/CO, ANTI-HBE = 0.08 S/CO, ANTI-HBC M = 0.14 S/CO. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323485 ALINITY I ANTI-HBC II REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT GMBH 75075BE00 00380740130039

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male ALNTY I PROCESSING MODU, 03R65-01, (B)(6)