BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I FREE T4 REAGENT KIT

    MDR report key: 23927715 · Received December 30, 2025

    Report

    Report Number
    3005094123-2025-00672
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Date of Event
    December 26, 2025
    Report Date
    March 30, 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

    DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. A REVIEW OF TRACKING AND TRENDING DATA IDENTIFIED AN INCREASE IN COMPLAINTS FOR THE ALINITY I FREE T4 ASSAY AS WELL AS AN INCREASE IN COMPLAINT ACTIVITY FOR REAGENT LOT 76559UD01. HOWEVER, TESTING WAS PERFORMED UTILIZING RETAINED KITS OF LOT 76559UD00 AND NOTED THAT ALL TESTING PASSED, INDICATING THE REAGENT LOTS ARE PERFORMING AS EXPECTED. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT AND COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE. PER THE LIMITATIONS OF THE PROCEDURE SECTION OF THE PACKAGE INSERT, RESULTS SHOULD BE USED IN CONJUNCTION WITH OTHER DATA, E.G., SYMPTOMS, RESULTS OF OTHER THYROID TESTS, CLINICAL IMPRESSIONS, ETC. IF THE FREE T4 RESULTS ARE INCONSISTENT WITH CLINICAL EVIDENCE, ADDITIONAL TESTING IS SUGGESTED TO CONFIRM THE RESULT. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I FREE T4 ASSAY, LOT 76559UD01 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 7P70-77 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P70, WITH 510K/PMA/BLA NUMBER K173122.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I FREE T4 RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT = 1.56 NG/DL, REPEAT = 0.89 NG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I FREE T4 RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT = 1.56 NG/DL, REPEAT = 0.89 NG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341017 ALINITY I FREE T4 REAGENT KIT RADIOIMMUNOASSAY, FREE THYROXINE CEC ABBOTT IRELAND DIAGNOSTICS DIVISION 76559UD01 00380740173715

    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).