ALINITY I FREE T4 REAGENT KIT

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I FREE T4 RESULT FOR A 32-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE IS 9.0-19.0 PMOL/L): SAMPLE ID (B)(6) INITIAL RESULT, ON (B)(6) 2026, WAS >64.35, REPEAT RESULT WAS 19.13, REPEAT RESULTS, ON ANOTHER ANALYZER, WERE 18.29, 18.17, AND 18.39 PMOL/L. THE TSH RESULTS FOR THIS PATIENT WERE ALSO PROVIDED: 2.521, REPEAT WAS 2.631 MIU/L. 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. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION.