ALINITY I FREE T4 REAGENT KIT

Description of Event or Problem

THE CUSTOMER OBSERVED ELEVATED ALINITY I FREE T4 AND PROVIDED THE FOLLOWING DATA: ON (B)(6) 2025, SAMPLE ID (B)(6) RESULT WAS 64 (CUSTOMER REFERENCE RANGE 9-19 PMOL/L). THE CUSTOMER REPORTED THAT THERE WAS NOT ENOUGH SAMPLE TO RETEST. THE CUSTOMER PROVIDED THE FOLLOWING HISTORICAL AND ADDITIONAL THYROID TEST RESULTS: ON (B)(6) 2024 SAMPLE ID (B)(6), FREE T4 WAS 15 PMOL/L WAS AND TSH WAS 3.42 MU/L. ON (B)(6) 2025 SAMPLE ID (B)(6), FREE T4 WAS 15 PMOL/L WAS AND TSH WAS 3.40 MU/L. ON (B)(6) 2024 SAMPLE ID (B)(6), FREE T4 WAS 14 PMOL/L WAS AND TSH WAS 5.68 MU/L. ON (B)(6) 2025, SAMPLE ID (B)(6) TSH WAS 1.29 MU/L. PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

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 ALINITY I FREE T4 ASSAY AS WELL AS AN INCREASE IN COMPLAINT ACTIVITY FOR REAGENT LOT 73465UD00. HOWEVER, ACCURACY TESTING WAS PERFORMED UTILIZING RETAINED KITS OF LOT 73465UD00 AND NOTED THAT ALL TESTING PASSED, INDICATING THE REAGENT LOT IS PERFORMING AS EXPECTED. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT NUMBER AND COMPLAINT ISSUE. PER THE LIMITATIONS OF THE PROCEDURE SECTION OF THE PACKAGE INSERT, RESULTS SHOULD BE USED IN CONJUNCTION WITH OTHER DATA, E.G., SYMPTOMS, RESULTS OF OTHER THYROID TESTS, CLINICAL IMPRESSIONS, ETC. IF THE FREE T4 RESULTS ARE INCONSISTENT WITH CLINICAL EVIDENCE, ADDITIONAL TESTING IS SUGGESTED TO CONFIRM THE RESULT. DETAILS AROUND REAGENT AND SPECIMEN HANDLING ARE OUTLINED IN THE PRODUCT PACKAGE INSERT, WHILE THE ALINITY I SYSTEM OPERATIONS MANUAL ALSO PROVIDES INFORMATION REGARDING FURTHER POTENTIAL CAUSES OF ELEVATED RESULTS. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I FREE T4 REAGENT, LOT 73465UD00 WAS IDENTIFIED.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER OBSERVED ELEVATED ALINITY I FREE T4 AND PROVIDED THE FOLLOWING DATA: ON (B)(6) 2025, SAMPLE ID (B)(6) RESULT WAS > 64 (CUSTOMER REFERENCE RANGE 9-19 PMOL/L). THE CUSTOMER REPORTED THAT THERE WAS NOT ENOUGH SAMPLE TO RETEST. THE CUSTOMER PROVIDED THE FOLLOWING HISTORICAL AND ADDITIONAL THYROID TEST RESULTS: ON (B)(6) 2024 (SAMPLE ID (B)(6), FREE T4 WAS 15 PMOL/L WAS AND TSH WAS 3.42 MU/L, ON (B)(6) 2025 (SAMPLE ID (B)(6), FREE T4 WAS 15 PMOL/L WAS AND TSH WAS 3.40 MU/L, ON (B)(6) 2024 (SAMPLE ID (B)(6), FREE T4 WAS 14 PMOL/L WAS AND TSH WAS 5.68 MU/L, ON (B)(6) 2025, SAMPLE ID (B)(6), TSH WAS 1.29 MU/L. PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.