ALINITY I FREE T4 REAGENT KIT

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 AND PROVIDED THE FOLLOWING DATA: CUSTOMER NORMAL RANGE : 0.70 - 1.48 NG/DL SAMPLE ID (B)(6) - MALE , 1 YEAR OLD. FREE T4 INITIAL RESULT WAS 2.88 NG/DL AND REPEAT RESULT WAS 0.76 NG/DL OTHER LABORATORY VALUES PROVIDED: FT3 : 2.46 PG/ML TSH : 1.8672 UIU/ML SAMPLE ID :(B)(6) - FEMALE , 16 YEAR OLD. FREE T4 INITIAL RESULT WAS > 5.00 NG/DL AND REPEAT RESULT WAS 1.16 NG/DL PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

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.