ALINITY I FREE T4 REAGENT KIT

Description of Event or Problem

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.

Additional Manufacturer Narrative

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.