ALINITY I FREE T4 REAGENT KIT

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 9 - 23 PMOL/L): (B)(6) 2026, SID (B)(6), INITIAL FREE T4 RESULT= 48.6 PMOL/L; REPEAT RESULTS= 17.4 AND 16.6 PMOL/L THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

COMPLETE ENTRY FOR SECTION A1 - PATIENT IDENTIFIER: (B)(6). 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.