BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HBSAG REAGENT KIT

    MDR report key: 23691628 · Received December 2, 2025

    Report

    Report Number
    3008344661-2025-00167
    Event Type
    Malfunction
    Date Received
    December 2, 2025
    Date of Event
    November 23, 2025
    Report Date
    January 7, 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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P08-77 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, ARCHITECT HBSAG, LIST NUMBER 04P53, WITH 510K/PMA/BLA NUMBER P110029.

    Additional Manufacturer Narrative · 0

    DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A REVIEW OF TRACKING AND TRENDING DID IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. HOWEVER, NO COMMONALITIES FOR THE COMPLAINT LOT AND ISSUE WERE IDENTIFIED. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT NUMBER AND COMPLAINT ISSUE. CLINICAL SENSITIVITY TESTING WAS PERFORMED USING AN IN-HOUSE RETAINED KIT OF LOT 72553FZ01 STORED AT THE RECOMMENDED STORAGE CONDITION. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I HBSAG REAGENT LOT 72553FZ01WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE NONREACTIVE ALINITY I HBSAG FOR A 63-YEAR-OLD MALE. THE FOLLOWING RESULT WERE PROVIDED (REFERENCE RANGE <0.05 IU/ML): (B)(6), INITIAL HBSAG RESULT= 0.02 IU/ML; REPEAT RESULT= 0.01 IU/ML; ROCHE METHOD RESULT= NEGATIVE; HBV DNA RESULT= WEAKLY POSITIVE (GRAYZONE). ADDITIONAL RESULTS WERE PROVIDED: ANTI-HBS= POSITIVE; ANTI-HBC= POSITIVE, ALL OTHER HEPATITIS B MARKERS WERE NEGATIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE NONREACTIVE ALINITY I HBSAG FOR A 63-YEAR-OLD MALE. THE FOLLOWING RESULT WERE PROVIDED (REFERENCE RANGE <0.05 IU/ML): SID (B)(6), INITIAL HBSAG RESULT= 0.02 IU/ML; REPEAT RESULT= 0.01 IU/ML; ROCHE METHOD RESULT= NEGATIVE; HBV DNA RESULT= WEAKLY POSITIVE (GRAYZONE) ADDITIONAL RESULTS WERE PROVIDED: ANTI-HBS= POSITIVE; ANTI-HBC= POSITIVE, ALL OTHER HEPATITIS B MARKERS WERE NEGATIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1899587 ALINITY I HBSAG REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 72553FZ01 00380740160104

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male ALNTY I PROCESSING MODU, 03R65-01, (B)(6).