BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HBSAG QUALITATIVE II CONFIRMATORY REAGENT KIT

    MDR report key: 23300052 · Received October 15, 2025

    Report

    Report Number
    3008344661-2025-00141
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 25, 2025
    Report Date
    December 2, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740130466
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 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 LOT 71088FZ00 IDENTIFIED NORMAL COMPLAINT ACTIVITY AND THERE ARE NO TRENDS FOR THE PRODUCT RELATED TO PATIENT RESULTS. NO CUSTOMER RETURNS WERE AVAILABLE FOR EVALUATION. ADDITIONALLY, CLINICAL SPECIFICITY OF THE ALINITY I HBSAG QUALITATIVE II CONFIRMATORY ASSAY HAS BEEN EVALUATED WITH A RETAINED IN-HOUSE KIT OF THE SAME LOT# 71088FZ00 AND MET ALL SPECIFICATIONS, CONFIRMING THAT THIS LOT IS MEETING THE ALINITY I HBSAG PRODUCT REQUIREMENTS. 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 (LOT# 71088FZ00).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE REACTIVE ALINITY I HBSAG QUALITATIVE II AND HBSAG CONFIRMATORY RESULTS ON A PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: SERUM (SST) = 1.2 / 1.8 S/CO, SST CONFIRMED POSITIVE AT 92% EDTA = 0.44 S/CO; EDTA AND LITHIUM HEPARIN SAMPLES DID NOT CONFIRM BY CONFIRMATORY ASSAY NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE REACTIVE ALINITY I HBSAG QUALITATIVE II AND HBSAG CONFIRMATORY RESULTS ON A PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: SERUM (SST) = 1.2 / 1.8 S/CO, SST CONFIRMED POSITIVE AT 92%. EDTA = 0.44 S/CO; EDTA AND LITHIUM HEPARIN SAMPLES DID NOT CONFIRM BY CONFIRMATORY ASSAY NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2004481 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 71088FZ00 00380740130466

    Patients

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