ALINITY I FREE T4 REAGENT KIT

Additional Manufacturer Narrative

DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A 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 THE COMPLAINT LOT. HOWEVER, TESTING WAS PERFORMED UTILIZING RETAINED KITS OF THE COMPLAINT LOT 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 LIST NUMBER. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I FREE T4 ASSAY, LOT 75088UD00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 RESULTS GENERATED FOR MULTIPLE PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE: 1-19 YEARS = 9.36-14.49 PMOL/L; >20 YEARS = 9.05-15.13 PMOL/L): SAMPLE ID (B)(6), 56-YEAR-OLD FEMALE (B)(6) 2025 INITIAL RESULT ON (B)(6) = 15.67 PMOL/L, REPEAT RESULT ON (B)(6) = 13.37 PMOL/L SAMPLE ID (B)(6), 38-YEAR-OLD MALE (B)(6)2025 INITIAL RESULT ON (B)(6) = 15.54 PMOL/L, REPEAT RESULT ON (B)(6) = 13.31 PMOL/L. SAMPLE ID (B)(6) 13-YEAR-OLD FEMALE (B)(60 2025 INITIAL RESULT ON (B)(6) = 16.10 PMOL/L, REPEAT RESULT ON (B)(6) = 11.12 PMOL/L. SAMPLE ID (B)(6) 25-YEAR-OLD FEMALE (B)(6) 2025 INITIAL RESULT ON (B)(6) = 30.95 PMOL/L, (B)(6) 2025 REPEAT RESULT ON (B)(6) = 14.73 PMOL/L. SAMPLE ID (B)(6),16-YEAR-OLD FEMALE (B)(6)2025 INITIAL RESULT ON (B)(6) = 14.6 PMOL/L, (B)(6) 2025 REPEAT RESULT ON (B)(^) = 11.36 PMOL/L SAMPLE ID (B)(6) 30-YEAR-OLD FEMALE (B)(6) 2025 INITIAL RESULT ON (B)(6) = 15.29 PMOL/L, (B)(6) 2025 REPEAT RESULT ON (B)(6) = 12.08 PMOL/L. SAMPLE ID (B)(6), 8-YEAR-OLD FEMALE (B)(6) 2025 INITIAL RESULT ON (B)(6) = 15.74 PMOL/L, (B)(6) 2025 REPEAT RESULT ON (B)(6) = 12.8 PMOL/L SAMPLE ID (B)(6), 17-YEAR-OLD MALE (B)(6) 2025 INITIAL RESULT ON (B)(6) = 15.77 PMOL/L, (B)(6) 2025 REPEAT RESULT ON (B)(6) = 12.36 PMOL/L. SAMPLE ID (B)(6), 48-YEAR-OLD FEMALE (B)(6) 2025 INITIAL RESULT ON (B)(6) = 16.48 PMOL/L, (B)(6) 2025 REPEAT RESULT ON (B)(6) = 14.31 PMOL/L . SAMPLE ID (B)(6), 71-YEAR-OLD FEMALE (B)(6) 2025 INITIAL RESULT ON (B)(6) = 16.27 PMOL/L, REPEAT RESULT ON (B)(6) = 13.14 PMOL/L. SAMPLE ID (B)(6),30-YEAR-OLD FEMALE (B)(6) 2025 INITIAL RESULT ON (B)(6) = 23.36 PMOL/L, (B)(6) 2025 REPEAT RESULT ON (B)(6) = 15.05 PMOL/L. SAMPLE ID (B)(6),4-YEAR-OLD MALE (B)(6) 2025 INITIAL RESULT ON (B)(6) = 15.41 PMOL/L, REPEAT RESULT ON (B)(6) = 12.53 PMOL/L. SAMPLE ID (B)(6), 43-YEAR-OLD FEMALE (B)(6) 2025 INITIAL RESULT ON (B)(6) = 18.14 PMOL/L, (B)(6) 2025 REPEAT RESULT ON (B)(6)= 11.26 PMOL/L. SAMPLE ID (B)(6), 40-YEAR-OLD FEMALE (B)(6)2025 INITIAL RESULT ON (B)(6) = 15.62 PMOL/L, REPEAT RESULT ON (B)(6) = 11.26 PMOL/L. SAMPLE ID (B)(6), 27-YEAR-OLD FEMALE (B)(6)2025 INITIAL RESULT ON (B)(6) = 15.28 PMOL/L, REPEAT RESULT ON (B)(6) = 13.34 PMOL/L. SAMPLE ID (B)(6), 44-YEAR-OLD MALE (B)(6) 2025 INITIAL RESULT ON (B)(6) = 18.14 PMOL/L, REPEAT RESULT ON (B)(6) = 13.48 PMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. COMPLETED INFORMATION FOR SECTION A1 - PATIENT IDENTIFIER: SIDS (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P70, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US WITH THE SAME LIST NUMBER, AND A 510K/PMA/BLA NUMBER OF K173122.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 RESULTS GENERATED FOR MULTIPLE PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE: 1-19 YEARS = 9.36-14.49 PMOL/L; >20 YEARS = 9.05-15.13 PMOL/L): SAMPLE ID (B)(6) 56-YEAR-OLD FEMALE (B)(6) 2025 INITIAL RESULT ON (B)(6) = 15.67 PMOL/L, REPEAT RESULT ON (B)(6) = 13.37 PMOL/L. SAMPLE ID (B)(6) 38-YEAR-OLD MALE (B)(6) 2025 INITIAL RESULT ON (B)(6) = 15.54 PMOL/L, REPEAT RESULT ON (B)(6) = 13.31 PMOL/L. SAMPLE ID (B)(6) 13-YEAR-OLD FEMALE (B)(6) 2025 INITIAL RESULT ON (B)(6) = 16.10 PMOL/L, REPEAT RESULT ON (B)(6) = 11.12 PMOL/L. SAMPLE ID (B)(6) 25-YEAR-OLD FEMALE (B)(6) 2025 INITIAL RESULT ON (B)(6) = 30.95 PMOL/L, (B)(6) 2025 REPEAT RESULT ON (B)(6) = 14.73 PMOL/L. SAMPLE ID (B)(6) 16-YEAR-OLD FEMALE (B)(6) 2025 INITIAL RESULT ON (B)(6) = 14.6 PMOL/L, (B)(6) 2025 REPEAT RESULT ON (B)(6) = 11.36 PMOL/L. SAMPLE ID (B)(6) 30-YEAR-OLD FEMALE (B)(6) 2025 INITIAL RESULT ON (B)(6) = 15.29 PMOL/L, (B)(6) 2025 REPEAT RESULT ON (B)(6) = 12.08 PMOL/L SAMPLE ID (B)(6) 8-YEAR-OLD FEMALE (B)(6) 2025 INITIAL RESULT ON (B)(6) = 15.74 PMOL/L, (B)(6) 2025 REPEAT RESULT ON (B)(6) = 12.8 PMOL/L. SAMPLE ID (B)(6) 17-YEAR-OLD MALE (B)(6) 2025 INITIAL RESULT ON (B)(6) = 15.77 PMOL/L, (B)(6) 2025 REPEAT RESULT ON (B)(6) = 12.36 PMOL/L. SAMPLE ID (B)(6) 48-YEAR-OLD FEMALE (B)(6) 2025 INITIAL RESULT ON (B)(6) = 16.48 PMOL/L, (B)(6) 2025 REPEAT RESULT ON (B)(6) = 14.31 PMOL/L. SAMPLE ID (B)(6) 71-YEAR-OLD FEMALE (B)(6) 2025 INITIAL RESULT ON (B)(6) = 16.27 PMOL/L, REPEAT RESULT ON (B)(6) = 13.14 PMOL/L. SAMPLE ID (B)(6) 30-YEAR-OLD FEMALE (B)(6) 2025 INITIAL RESULT ON (B)(6) = 23.36 PMOL/L, (B)(6) 2025 REPEAT RESULT ON (B)(6) = 15.05 PMOL/L SAMPLE ID (B)(6) 4-YEAR-OLD MALE (B)(6) 2025 INITIAL RESULT ON (B)(6) = 15.41 PMOL/L, REPEAT RESULT ON (B)(6) = 12.53 PMOL/L. SAMPLE ID (B)(6) 43-YEAR-OLD FEMALE (B)(6) 2025 INITIAL RESULT ON (B)(6) = 18.14 PMOL/L, (B)(6) 2025 REPEAT RESULT ON (B)(6) = 11.26 PMOL/L. SAMPLE ID (B)(6) 40-YEAR-OLD FEMALE (B)(6) 2025 INITIAL RESULT ON (B)(6) = 15.62 PMOL/L, REPEAT RESULT ON (B)(6) = 11.26 PMOL/L. SAMPLE ID (B)(6) 27-YEAR-OLD FEMALE (B)(6) 2025 INITIAL RESULT ON (B)(6) = 15.28 PMOL/L, REPEAT RESULT ON (B)(6) = 13.34 PMOL/L. SAMPLE ID (B)(6) 44-YEAR-OLD MALE (B)(6) 2025 INITIAL RESULT ON (B)(6) = 18.14 PMOL/L, REPEAT RESULT ON (B)(6) = 13.48 PMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.