ALINITY I FREE T4 REAGENT KIT

Description of Event or Problem

A CONFERENCE ABSTRACT BY CULLEN, M.R., AND LEE, G.R., ¿EVALUATION OF FREE THYROXINE AND HIGH SENSITIVITY CARDIAC TROPONIN DUPLICATE TESTING,¿ CLINICAL CHEMISTRY AND LABORATORY MEDICINE, 2026; 64(4): EA78. DOI: 10.1515/CCLM-2026-0148, DESCRIBES THE USE OF ROUTINE DUPLICATE TESTING AS A RISK MANAGEMENT STRATEGY TO DETECT ANALYTICAL ERRORS IN ELEVATED ALINITY I FREE T4 RESULTS GENERATED BY THE ALINITY I PROCESSING MODULES. DUPLICATE TESTING WAS PERFORMED FOR ALL ELEVATED ALINITY I FREE T4 RESULTS >20 PMOL/L. RESULTS WERE ASSESSED USING A PREDEFINED ACCEPTABILITY CRITERION OF A >20% DIFFERENCE AT CONCENTRATIONS =20 PMOL/L. NINETY-TWO DUPLICATE PAIRS WERE ANALYZED, FROM WHICH ONLY ONE DEMONSTRATED AN ANALYTICAL ERROR (1.1%). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

SECTION E: E1: ADDRESS 1: COMPLETE ADDRESS INFORMATION: (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.