BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I FREE T4 REAGENT KIT

    MDR report key: 25016385 · Received April 28, 2026

    Report

    Report Number
    3005094123-2026-00196
    Event Type
    Malfunction
    Date Received
    April 28, 2026
    Date of Event
    April 19, 2026
    Report Date
    April 28, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    CEC
    UDI-DI
    00380740173715
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P70 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07P70, WITH 510K NUMBER K173122. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I FREE T4 FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE: 0.70-1.48 NG/DL): INITIAL FREE T4 RESULT= 1.78 NG/DL; REPEAT RESULT= 1.06 NG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626458 ALINITY I FREE T4 REAGENT KIT RADIOIMMUNOASSAY, FREE THYROXINE CEC ABBOTT IRELAND DIAGNOSTICS DIVISION 82597UD01 00380740173715

    Patients

    Seq Age Sex Outcome Treatment
    1