ALINITY I FREE T4 REAGENT KIT

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 RESULTS FOR ONE 63-YEAR-OLD FEMALE, HOSPITALIZED FOR ILEUS. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2025 SID (B)(6) >5.0 NG/DL, REPEATED >5 NG/DL; SERUM SAMPLE 1.01 NG/DL, (B)(6) 2025 SID (B)(6) >5.0 NG/DL, REPEATED 2.08 / 1.01 / 1.18 / 1.27 / 2.84 / 2.81 NG/DL; SERUM SAMPLE 2.08 NG/DL; TSH 1.71 UIU/ML, FREE T3 2.78 PG/ML. HISTORICAL RESULTS: 31OCT2025 FREE T4 RESULT 1.15 NG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A SEARCH FOR SIMILAR COMPLAINTS DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 75641D00. A REVIEW OF TRACKING AND TRENDING DATA FOR THE ALINITY I FREE T4 ASSAY DID IDENTIFY AN INCREASE IN COMPLAINTS; HOWEVER, IN-HOUSE PERFORMANCE TESTING WAS PERFORMED UTILIZING RETAINED REAGENT KIT OF THE COMPLAINT LOT. ALL TESTING PASSED, INDICATING THE REAGENT LOT IS PERFORMING AS EXPECTED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH LOT NUMBER 75641UD00 AND THE COMPLAINT ISSUE. A REVIEW OF LABELING WAS PERFORMED AND FOUND TO SUFFICIENTLY ADDRESS THE CUSTOMER'S ISSUE. BASED ON THIS INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ALINITY I FREE T4 REAGENT, LOT NUMBER 75641UD00.A

Additional Manufacturer Narrative

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

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 RESULTS FOR ONE 63-YEAR-OLD FEMALE, HOSPITALIZED FOR ILEUS. THE FOLLOWING DATA WAS PROVIDED: 12DEC2025 SID (B)(6) >5.0 NG/DL, REPEATED >5 NG/DL; SERUM SAMPLE 1.01 NG/DL, 17DEC2025 SID (B)(6) >5.0 NG/DL, REPEATED 2.08 / 1.01 / 1.18 / 1.27 / 2.84 / 2.81 NG/DL; SERUM SAMPLE 2.08 NG/DL; TSH 1.71 UIU/ML, FREE T3 2.78 PG/ML. HISTORICAL RESULTS: 31OCT2025 FREE T4 RESULT 1.15 NG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.