BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HBSAG REAGENT KIT

    MDR report key: 23745043 · Received December 8, 2025

    Report

    Report Number
    3008344661-2025-00172
    Event Type
    Malfunction
    Date Received
    December 8, 2025
    Date of Event
    November 19, 2025
    Report Date
    January 27, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740130169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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, LABELING REVIEW, AND DEVICE HISTORY RECORD REVIEW. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS REGARDING THE COMMONALITIES FOR THE CURRENT ISSUE. A REVIEW IN THE CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) SYSTEM DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES, OR DEVIATIONS ASSOCIATED WITH THE LIST NUMBER AND COMPLAINT ISSUE. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES SAFETY HAZARDS INCLUDING THE WEARING OF PERSONAL PROTECTIVE EQUIPMENT (PPE) AND SAFETY AWARENESS WHERE HAZARDS MAY EXIST. BASED ON THE INVESTIGATION, THE ALINITY I HBSAG CONTROLS, LIST NUMBER 08P08-10, WHICH IS USED FOR THE ALINITY I HBSAG ASSAY, IS PERFORMING AS INTENDED, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    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 08P08 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 04P53, WITH 510K/PMA/BLA NUMBER P110029.

    Description of Event or Problem · 0

    AFTER THE CUSTOMER PERFORMED AN ALINITY I HBSAG CONTROL TEST FOR THE ALINITY I HBSAG ASSAY, SOME CONTROL LIQUID SPLASHED ONTO THE CUSTOMER WHEN THEY WERE DISPOSING OF THE CONTROL SAMPLE. IT IS UNCLEAR IF THE LIQUID SPLASHED INTO THEIR EYES, HOWEVER THEY WERE NOT WEARING PROTECTIVE EYE WEAR. THE CUSTOMER WASHED THEIR EYES AND REPLACED THEIR CONTACT LENSES. THERE WAS NO MEDICAL INTERVENTION / TREATMENT REPORTED. THERE WAS NO FURTHER IMPACT TO PATIENT MANAGEMENT OR USER SAFETY REPORTED.

    Description of Event or Problem · 0

    AFTER THE CUSTOMER PERFORMED AN ALINITY I HBSAG CONTROL TEST FOR THE ALINITY I HBSAG ASSAY, SOME CONTROL LIQUID SPLASHED ONTO THE CUSTOMER WHEN THEY WERE DISPOSING OF THE CONTROL SAMPLE. IT IS UNCLEAR IF THE LIQUID SPLASHED INTO THEIR EYES, HOWEVER THEY WERE NOT WEARING PROTECTIVE EYE WEAR. THE CUSTOMER WASHED THEIR EYES AND REPLACED THEIR CONTACT LENSES. THERE WAS NO MEDICAL INTERVENTION / TREATMENT REPORTED. THERE WAS NO FURTHER IMPACT TO PATIENT MANAGEMENT OR USER SAFETY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139648 ALINITY I HBSAG REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 72550FZ00 00380740130169

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY I HBS AG QUANT CT, (B)(6).