BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-HBC II REAGENT KIT

    MDR report key: 23532104 · Received November 12, 2025

    Report

    Report Number
    3002809144-2025-00359
    Event Type
    Malfunction
    Date Received
    November 12, 2025
    Date of Event
    November 3, 2025
    Report Date
    January 6, 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 FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A1 - PATIENT IDENTIFIER COMPLETE ENTRY = (B)(6). SECTION E1 - INITIAL REPORTER ESTABLISHMENT NAME COMPLETE ENTRY = HUBEI MATERNAL AND CHILD HEALTH HOSPITAL (HONGSHAN BRANCH) SECTION E1 - ADDRESS 1 COMPLETE ENTRY = (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P87 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P84 AND A 510K/PMA/BLA NUMBER OF P080023.

    Additional Manufacturer Narrative · 0

    DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I ANTI-HBC II ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 71418BE01. THE DEVICE HISTORY RECORD REVIEW FOR LOT 71418BE01 DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES, OR DEVIATIONS. IN-HOUSE TESTING OF A RETAINED REAGENT KIT OF THE ALINITY I ANTI-HBC II COMPLAINT LOT WAS PERFORMED. ALL SPECIFICATIONS WERE MET, AND NO FALSE NON-REACTIVE RESULTS WERE OBTAINED, SHOWING THAT THE LOT GENERATES THE EXPECTED RESULTS. IN ADDITION, THE CLINICAL SENSITIVITY OF THE LOT WAS EVALUATED BY TESTING A COMMERCIALLY AVAILABLE SEROCONVERSION PANEL (BIOMEX SEROCONVERSION PANEL SCP-HBV-001). THE SEROCONVERSION PANEL RESULTS WERE COMPARED TO ARCHITECT ANTI-HBC II TEST RESULTS PROVIDED BY BIOMEX. THE LOT DETECTED THE SAME BLEEDS AS REACTIVE FOR THE SEROCONVERSION PANEL. BASED ON THESE DATA IT WAS SHOWN THAT THE SENSITIVITY PERFORMANCE OF THE COMPLAINT LOT IS NOT ADVERSELY AFFECTED. NOTE: ALINITY I ANTI-HBC II AND ARCHITECT ANTI-HBC II UTILIZE THE SAME REAGENTS AND SAMPLE/REAGENT RATIOS. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I ANTI-HBC II REAGENT LOT NUMBER 71418BE01 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE NON-REACTIVE ALINITY I ANTI-HBC II RESULT GENERATED FOR A 32-YEAR-OLD FEMALE PATIENT WHO HAS A HISTORY OF BEING HEPATITIS B POSITIVE. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE < 1.00 S/CO IS NON-REACTIVE): SAMPLE ID (B)(6) INITIAL RESULT = 0.39 S/CO, REPEAT RESULT = 4.33 S/CO NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE NON-REACTIVE ALINITY I ANTI-HBC II RESULT GENERATED FOR A 32-YEAR-OLD FEMALE PATIENT WHO HAS A HISTORY OF BEING HEPATITIS B POSITIVE. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE < 1.00 S/CO IS NON-REACTIVE): SAMPLE ID (B)(6) INITIAL RESULT = 0.39 S/CO, REPEAT RESULT = 4.33 S/CO. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315614 ALINITY I ANTI-HBC II REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT GMBH 71418BE01 00380740162580

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)