Alinity I Free T4 Reagent Kit

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I FREE T4 RESULT GENERATED ON AN ALINITY I PROCESSING MODULE FOR A 55-YEAR-OLD MALE PATIENT. SID 632 INITIAL RESULT = 21.86 PMOL/L, REPEAT RESULT = 11.92 PMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.