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, NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 RESULTS FOR A 72-YEAR-OLD FEMALE PATIENT. "ON" (B)(6) 2026, ALINITY I FREE T4 RESULT FOR SID (B)(6) WAS 3.57 NG/DL, REPEATED AFTER RE-CENTRIFUGATION >5.00 NG/DL. OTHER TESTING PERFORMED: LUMIPULSE 1.12 NG/DL, COBAS 1.09 NG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.