BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HBSAG QUALITATIVE II CONFIRMATORY REAGENT KIT

    MDR report key: 22837544 · Received August 19, 2025

    Report

    Report Number
    3008344661-2025-00114
    Event Type
    Malfunction
    Date Received
    August 19, 2025
    Date of Event
    July 25, 2025
    Report Date
    October 2, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    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. SECTION A1 PATIENT IDENTIFIER COMPLETE SID: (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P11-22 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P11-21, WITH 510K/PMA/BLA NUMBER P110029.

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF COMPLAINT DATA FOR THE PRODUCT AND LIKELY CAUSE ALINITY I HBSAG QUALITATIVE II CONFIRMATORY COULD NOT BE PERFORMED AS THE LOT# IS UNKNOWN. ADDITIONALLY, CLINICAL SPECIFICITY TESTING WAS NOT PERFORMED BECAUSE THE LOT NUMBER WAS UNKNOWN. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMERS OBSERVATION. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ALINITY I HBSAG QUALITATIVE II CONFIRMATORY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE REPEAT REACTIVE ALINITY I HBSAG QUALITATIVE II RESULT ON A PATIENT, THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025, SID (B)(6) = 22.484 / 24.6 / 23.9 S/CO, CONFIRMATORY TEST: N% = 99. NEW SAMPLE ON (B)(6) 2025, SID (B)(6) = 0.443S/CO (NONREACTIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE REPEAT REACTIVE ALINITY I HBSAG QUALITATIVE II RESULT ON A PATIENT, THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025 SID (B)(6) = 22.484 / 24.6 / 23.9 S/CO, CONFIRMATORY TEST: N% = 99. NEW SAMPLE ON (B)(6) 2025 SID (B)(6) = 0.443S/CO (NONREACTIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2663705 ALINITY I HBSAG QUALITATIVE II CONFIRMATORY REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION

    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).