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

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I FREE T4 RESULT GENERATED ON AN ALINITY I PROCESSING MODULE, (B)(6), FOR ONE PATIENT. SID (B)(6) INITIAL RESULT = 1.46 NG/DL, REPEAT RESULT = 1.06 NG/DL. NEW SAMPLE WAS RUN ON ANOTHER ALINITY I, (B)(6): INITIAL RESULT = 1.13 NG/DL, REPEAT RESULT = 1.09 NG/DL. THE SAMPLE WAS REPEATED ON ANOTHER ALINITY I, (B)(6), GENERATING A RESULT OF 1.16 NG/DL AND REPEATED ON ANOTHER ALINITY I, (B)(6), GENERATING A RESULT OF 1.13 NG/DL. (CUSTOMER REFERENCE RANGE: 0.75 TO 1.22 NG/DL). THERE WAS NO IMPACT TO PATIENT MANAGEMENT.