BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HBSAG REAGENT KIT

    MDR report key: 23887721 · Received December 24, 2025

    Report

    Report Number
    3008344661-2025-00189
    Event Type
    Malfunction
    Date Received
    December 24, 2025
    Date of Event
    December 20, 2025
    Report Date
    February 4, 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 6C36 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4P53, WITH 510K/PMA/BLA NUMBER P110029.

    Additional Manufacturer Narrative · 0

    A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ALINITY I HBSAG REAGENT, LOT 75091FZ01. REVIEW OF TRACKING AND TRENDING BY LIST NUMBER AND BY COMPLAINT LOT DID NOT IDENTIFY ANY TRENDS. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT ISSUE. CLINICAL SENSITIVITY TESTING WAS PERFORMED USING AN IN-HOUSE RETAINED KIT OF LOT 75091FZ01. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ALINITY I HBSAG REAGENT, LOT 75091FZ01.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY DEPRESSED ALINITY I HBSAG RESULTS FOR A 56 YEAR OLD MALE DIALYSIS PATIENT. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT = 0.03 IU/ML (NEGATIVE), REPEATS = 0.02 IU/ML AND 0.03 IU/ML (NEGATIVE), ROCHE = 1.20 COI (POSITIVE), DIASORIN (AT ANOTHER HOSPITAL) = 0.13 IU/ML (POSITIVE) ADDITIONAL LABORATORY DATA WAS PROVIDED: ANTI-HBS, ANTI-HBE, ANTI-HBC WERE POSITIVE AND HBEAG WAS NEGATIVE. THE PATIENT WAS DIAGNOSED AS A HEPATITIS B CARRIER 10 YEARS AGO. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY DEPRESSED ALINITY I HBSAG RESULTS FOR A 56 YEAR OLD MALE DIALYSIS PATIENT. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT = 0.03 IU/ML (NEGATIVE), REPEATS = 0.02 IU/ML AND 0.03 IU/ML (NEGATIVE), ROCHE = 1.20 COI (POSITIVE), DIASORIN (AT ANOTHER HOSPITAL) = 0.13 IU/ML (POSITIVE) ADDITIONAL LABORATORY DATA WAS PROVIDED: ANTI-HBS, ANTI-HBE, ANTI-HBC WERE POSITIVE AND HBEAG WAS NEGATIVE. THE PATIENT WAS DIAGNOSED AS A HEPATITIS B CARRIER 10 YEARS AGO. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1828600 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 56 YR Male ALNTY I PROCESSING MODU, 03R65-01, (B)(6)