BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-HBS REAGENT KIT

    MDR report key: 24389485 · Received February 19, 2026

    Report

    Report Number
    3008344661-2026-00038
    Event Type
    Malfunction
    Date Received
    February 19, 2026
    Date of Event
    February 10, 2026
    Report Date
    April 29, 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. UPDATED SECTION B6: DESCRIBE EVENT OR PROBLEM: ADDITIONAL INFORMATION PROVIDED ON 27FEB2026: SID (B)(6) =HBV DNA TEST RESULT WAS NEGATIVE.

    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, WITH 510K/PMA/BLA NUMBER P050051.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I ANTI-HBS RESULTS ON FOUR PATIENTS, THAT WERE REPORTED TO MEDICAL PROVIDER. THE FOLLOWING DATA WAS PROVIDED. SID (B)(6), (B)(6) FEMALE = 10.78 MIU/ML, SID (B)(6), 86 YEARS OLD FEMALE =13.23 MIU/ML, SID (B)(6), 48 YEARS OLD FEMALE = 11.57 MIU/ML, SID (B)(6), 52 YEARS OLD MALE =34.86 MIU/ML, THE CUSTOMER USES REFERENCE RANGE =<10 MIU/ML. ADDITIONAL INFORMATION PROVIDED ON 27FEB2026: SID (B)(6) = HBV DNA TEST RESULT WAS NEGATIVE, NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I ANTI-HBS RESULTS ON FOUR PATIENTS, THAT WERE REPORTED TO MEDICAL PROVIDER. THE FOLLOWING DATA WAS PROVIDED. SID (B)(6) , 91 YEARS OLD FEMALE = 10.78 MIU/ML SID (B)(6) , 86 YEADS OLD FEMALE =13.23 MIU/ML SID (B)(6) , 48 YEARS OLD FEMALE = 11.57 MIU/ML SID (B)(6) , 52 YEARS OLD MALE =34.86 MIU/ML THE CUSTOMER USES REFERENCE RANGE =<10 MIU/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447266 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 NA Unknown ALNTY I PROCESSING MODU, 03R65-01, (B)(6).| ALNTY I PROCESSING MODU, 03R65-01, (B)(6).