BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HBSAG QUALITATIVE II REAGENT KIT

    MDR report key: 23309281 · Received October 16, 2025

    Report

    Report Number
    3008344661-2025-00143
    Event Type
    Malfunction
    Date Received
    October 16, 2025
    Date of Event
    November 1, 2019
    Report Date
    November 20, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740130398
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER: 08P10-22, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER: 08P10-21/-31, WITH PMA NUMBER: P110029. 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.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, DEVICE HISTORY RECORD REVIEW, FIELD DATA REVIEW AND LABELING REVIEW. DATA AND INFORMATION PROVIDED IN THE ARTICLE WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. THE TICKET TRENDING REVIEW FOR THE ALINITY I HBSAG QUALITATIVE II DID NOT IDENTIFY ANY TREND REGARDING COMMONALITIES FOR THE ISSUE. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT ISSUE. CUSTOMER FIELD DATA WAS USED TO ASSESS THE PERFORMANCE OF THE ALINITY I HBSAG QUALITATIVE II ASSAY USING WORLDWIDE DATA. REVIEW SHOWS THAT THE MEDIAN PATIENT RESULTS FOR ALL REVIEWED LOTS ARE COMPARABLE AND WITHIN ESTABLISHED LIMITS, CONFIRMING NO SYSTEMIC ISSUE FOR THE LOTS. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I HBSAG QUALITATIVE II ASSAY WAS IDENTIFIED.

    Description of Event or Problem · 0

    A LITERATURE ARTICLE BY WAJNAT A. TOUNSI, ET.AL., ¿THE ¿GREY ZONE¿ IN BLOOD DONOR SCREENING: A RETROSPECTIVE STUDY AND PROPOSAL FOR DONOR RE-ENTRY¿, DIAGNOSTICS 2025, 15, 2261. MDPI AG, DOCUMENTED FALSE NONREACTIVE ANTI-HBC, HBSAG, ANTI-HCV, HTLV, AND SYPHILIS, FOR DONOR SAMPLES. THE DONOR BLOOD SCREENING WAS PERFORMED ON THE ARCHITECT SYSTEM AND, LATER IN THE STUDY, THE ALINITY I SYSTEM. A RETROACTIVE STUDY WAS PERFORMED FOR DONOR SAMPLES COLLECTED BETWEEN NOVEMBER 2019 AND NOVEMBER 2024. DONOR SAMPLE RESULTS FOR HBSAG, ANTI-HBC, HCV ANTIBODY, HIV ANTIGEN/ANTIBODY COMBO, HTLV ANTIBODY, AND SYPHILIS ANTIBODY WERE COLLECTED FOR INITIAL SCREENING, REPEAT 1 AND 2 TESTS, AS WELL AS NAT RESULTS FOR HIV, HCV, AND HBV. A TOTAL OF 48,241 BLOOD DONATIONS, WITH 38,562 UNIQUE DONORS, WERE TESTED. INITIAL SCREENING RESULTS WERE INTERPRETED AS REACTIVE (S/CO = 1.0), GREY ZONE (0.90 = S/CO < 1.0), OR NONREACTIVE (S/CO < 0.90) WITH REPEAT TESTING PERFORMED FOR SAMPLES WITH AN INTERPRETATION OF GREY ZONE OR REACTIVE. THE FOLLOWING INFORMATION WAS PROVIDED: 76 DONOR SAMPLES HAD INITIAL RESULTS IN GREY ZONE FOR ANTI-HBC, OF WHICH 24 REPEATED AS REACTIVE. 28 DONOR SAMPLES HAD INITIAL RESULTS IN GREY ZONE FOR HBSAG, OF WHICH 8 REPEATED AS REACTIVE. 39 DONOR SAMPLES HAD INITIAL RESULTS IN GREY ZONE FOR ANTI-HCV, OF WHICH 11 REPEATED AS REACTIVE. 20 DONOR SAMPLES HAD INITIAL RESULTS IN GREY ZONE FOR HTLV, OF WHICH 3 REPEATED AS REACTIVE. 36 DONOR SAMPLES HAD INITIAL RESULT IN GREY ZONE FOR SYPHILIS, OF WHICH 11 REPEATED REACTIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    A LITERATURE ARTICLE BY WAJNAT A. TOUNSI, ET.AL., ¿THE ¿GREY ZONE¿ IN BLOOD DONOR SCREENING: A RETROSPECTIVE STUDY AND PROPOSAL FOR DONOR RE-ENTRY¿, DIAGNOSTICS 2025, 15, 2261. MDPI AG, DOCUMENTED FALSE NONREACTIVE ANTI-HBC, HBSAG, ANTI-HCV, HTLV, AND SYPHILIS, FOR DONOR SAMPLES. THE DONOR BLOOD SCREENING WAS PERFORMED ON THE ARCHITECT SYSTEM AND, LATER IN THE STUDY, THE ALINITY I SYSTEM. A RETROACTIVE STUDY WAS PERFORMED FOR DONOR SAMPLES COLLECTED BETWEEN NOVEMBER 2019 AND NOVEMBER 2024. DONOR SAMPLE RESULTS FOR HBSAG, ANTI-HBC, HCV ANTIBODY, HIV ANTIGEN/ANTIBODY COMBO, HTLV ANTIBODY, AND SYPHILIS ANTIBODY WERE COLLECTED FOR INITIAL SCREENING, REPEAT 1 AND 2 TESTS, AS WELL AS NAT RESULTS FOR HIV, HCV, AND HBV. A TOTAL OF 48,241 BLOOD DONATIONS, WITH 38,562 UNIQUE DONORS, WERE TESTED. INITIAL SCREENING RESULTS WERE INTERPRETED AS REACTIVE (S/CO = 1.0), GREY ZONE (0.90 = S/CO < 1.0), OR NONREACTIVE (S/CO < 0.90) WITH REPEAT TESTING PERFORMED FOR SAMPLES WITH AN INTERPRETATION OF GREY ZONE OR REACTIVE. THE FOLLOWING INFORMATION WAS PROVIDED: 76 DONOR SAMPLES HAD INITIAL RESULTS IN GREY ZONE FOR ANTI-HBC, OF WHICH 24 REPEATED AS REACTIVE. 28 DONOR SAMPLES HAD INITIAL RESULTS IN GREY ZONE FOR HBSAG, OF WHICH 8 REPEATED AS REACTIVE. 39 DONOR SAMPLES HAD INITIAL RESULTS IN GREY ZONE FOR ANTI-HCV, OF WHICH 11 REPEATED AS REACTIVE. 20 DONOR SAMPLES HAD INITIAL RESULTS IN GREY ZONE FOR HTLV, OF WHICH 3 REPEATED AS REACTIVE. 36 DONOR SAMPLES HAD INITIAL RESULT IN GREY ZONE FOR SYPHILIS, OF WHICH 11 REPEATED REACTIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2374103 ALINITY I HBSAG QUALITATIVE II REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 00380740130398

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY I PROCESSING MODU, 03R65-01, 205UNKNOWND11.