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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. ADDITIONAL INFORMATION FOR SECTION H10 RELATED REPORT NUMBERS: 3005094123-2025-00477 3005094123-2025-00478. 3005094123-2025-00480. 3005094123-2025-00481.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I FREE T4 RESULTS FOR MULTIPLE PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED (PACKAGE INSERT REFERENCE RANGE USED BY THE CUSTOMER IS 0.70 TO 1.48 NG/DL): (B)(6) 2024: INITIAL RESULT = 2.45 NG/DL, REPEAT = 1.07 NG/DL (B)(6): INITIAL RESULT WAS >5 NG/DL, REPEAT WAS >5 NG/DL, REPEAT ON NOVEMBER 07 = 0.92 NG/DL (B)(6): INITIAL RESULT = 2.2 NG/DL, REPEAT = 1.22 NG/DL (B)(6): INITIAL RESULT = 1.53 NG/DL, REPEAT = 1.34 NG/DL (B)(6): INITIAL RESULT WAS >5 NG/DL, REPEAT = 1.11 NG/DL (B)(6), 2025: INITIAL RESULT = 1.64 NG/DL, REPEAT = 1.09 NG/DL (B)(6): INITIAL RESULT = 2.17 NG/DL, REPEAT = 1.35 NG/DL (B)(6): INITIAL RESULT = 5 NG/DL, REPEAT = 3.77 NG/DL (B)(6): (SECOND): INITIAL RESULT = 1.94 NG/DL, REPEAT = 1.20 NG/DL (B)(6): INITIAL RESULT = 1.50 NG/DL, REPEAT = 1.33 NG/DL (B)(6): INITIAL RESULT WAS >5 NG/DL, REPEAT = 1.36 NG/DL (B)(6): INITIAL RESULT = 1.69 NG/DL, REPEAT = 1.43 NG/DL (B)(6): INITIAL RESULT WAS >5 NG/DL, REPEAT = 1.76 NG/DL (B)(6): INITIAL RESULT = 1.72 NG/DL, REPEAT = 1.46 NG/DL (B)(6): INITIAL RESULT = 1.62 NG/DL, REPEAT = 1.13 NG/DL (B)(6): INITIAL RESULT = 1.52 NG/DL, REPEAT = 1.11 NG/DL (B)(6): INITIAL RESULT = 1.92 NG/DL, REPEAT = 1.14 NG/DL (B)(6): INITIAL RESULT = 1.65 NG/DL, REPEAT = 1.42 NG/DL (B)(6): INITIAL RESULT = 1.73 NG/DL, REPEAT = 1.27 NG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I FREE T4 RESULTS FOR MULTIPLE PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED (PACKAGE INSERT REFERENCE RANGE USED BY THE CUSTOMER IS 0.70 TO 1.48 NG/DL): (B)(6) 2024: INITIAL RESULT = 2.45 NG/DL, REPEAT = 1.07 NG/DL. (B)(6): INITIAL RESULT WAS >5 NG/DL, REPEAT WAS >5 NG/DL, REPEAT ON NOVEMBER 07 = 0.92 NG/DL. (B)(6): INITIAL RESULT = 2.2 NG/DL, REPEAT = 1.22 NG/DL. (B)(6): INITIAL RESULT = 1.53 NG/DL, REPEAT = 1.34 NG/DL. (B)(6): INITIAL RESULT WAS >5 NG/DL, REPEAT = 1.11 NG/DL. (B)(6) 2025: INITIAL RESULT = 1.64 NG/DL, REPEAT = 1.09 NG/DL. (B)(6): INITIAL RESULT = 2.17 NG/DL, REPEAT = 1.35 NG/DL. (B)(6): INITIAL RESULT = 5 NG/DL, REPEAT = 3.77 NG/DL. (B)(6) (SECOND): INITIAL RESULT = 1.94 NG/DL, REPEAT = 1.20 NG/DL. (B)(6): INITIAL RESULT = 1.50 NG/DL, REPEAT = 1.33 NG/DL. (B)(6): INITIAL RESULT WAS >5 NG/DL, REPEAT = 1.36 NG/DL. (B)(6): INITIAL RESULT = 1.69 NG/DL, REPEAT = 1.43 NG/DL. (B)(6): INITIAL RESULT WAS >5 NG/DL, REPEAT = 1.76 NG/DL. (B)(6): INITIAL RESULT = 1.72 NG/DL, REPEAT = 1.46 NG/DL. (B)(6): INITIAL RESULT = 1.62 NG/DL, REPEAT = 1.13 NG/DL. (B)(6): INITIAL RESULT = 1.52 NG/DL, REPEAT = 1.11 NG/DL. (B)(6): INITIAL RESULT = 1.92 NG/DL, REPEAT = 1.14 NG/DL. (B)(6): INITIAL RESULT = 1.65 NG/DL, REPEAT = 1.42 NG/DL. (B)(6): INITIAL RESULT = 1.73 NG/DL, REPEAT = 1.27 NG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. REVIEW OF TRACKING AND TRENDING DATA IDENTIFIED AN INCREASE IN COMPLAINTS FOR THE ARCHITECT FREE T4 ASSAY AS WELL AS AN INCREASE IN COMPLAINT ACTIVITY FOR THE COMPLAINT LOTS. HOWEVER, TESTING WAS PERFORMED UTILIZING RETAINED KITS OF THE COMPLAINT LOTS AND NOTED THAT ALL TESTING PASSED, INDICATING THE REAGENT LOTS ARE PERFORMING AS EXPECTED. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY RELATED NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE ARCHITECT FREE T4 ASSAY AND COMPLAINT ISSUE. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT FREE T4 ASSAY, LOTS 8901UD00, 68517UD00, 65267UD00, 71236UD00 AND 73276UD00 WERE IDENTIFIED.