BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-HBS REAGENT KIT

    MDR report key: 24213202 · Received January 29, 2026

    Report

    Report Number
    3008344661-2026-00018
    Event Type
    Malfunction
    Date Received
    January 29, 2026
    Date of Event
    January 20, 2026
    Report Date
    February 3, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740159894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ALINITY I ANTI-HBS REAGENT LOT 76183FZ01. REVIEW OF TRACKING AND TRENDING BY LIST NUMBER AND BY COMPLAINT LOT DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO REAGENT LOT 76183FZ01. DEVICE HISTORY REVIEW DID NOT IDENTIFY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. CUSTOMER FIELD DATA WAS USED TO ASSESS THE PERFORMANCE OF THE ALINITY I ANTI-HBS ASSAY USING WORLDWIDE DATA. REVIEW SHOWS THAT THE MEDIAN PATIENT RESULT FOR THE LOT IS WITHIN ESTABLISHED LIMITS AND COMPARABLE WITH OTHER LOTS IN THE FIELD, CONFIRMING THAT THE LOT IS PERFORMING ACCEPTABLY. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ALINITY I ANTI-HBS REAGENT LOT 76183FZ01.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FINAL 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 7P89 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P88, WITH 510K/PMA/BLA NUMBER P050051.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE REACTIVE ALINITY I ANTI-HBS RESULT ON A PATIENT THAT WAS NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING RESULTS ARE PROVIDED: INITIAL RESULT = 24.17 MIU/ML. REFERENCE RANGE = 10 MIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE REACTIVE ALINITY I ANTI-HBS RESULT ON A PATIENT THAT WAS NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING RESULTS ARE PROVIDED: INITIAL RESULT = 24.17 MIU/ML. REFERENCE RANGE = <10 MIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271117 ALINITY I ANTI-HBS REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 76183FZ01 00380740159894

    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)