ALINITY I FREE T4 REAGENT KIT

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, A SEARCH FOR SIMILAR COMPLAINTS, A TICKET TRENDING REVIEW, A DEVICE HISTORY RECORD REVIEW, A LABELING REVIEW, AND IN-HOUSE TESTING. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. REVIEW OF TRACKING AND TRENDING DATA FOR THE ALINITY I FREE T4 ASSAY DID IDENTIFY AN INCREASE IN COMPLAINTS. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS IDENTIFIED FOR REAGENT LOT 79271UD01; HOWEVER, IN-HOUSE ACCURACY TESTING WAS COMPLETED WITH A RETAINED KIT OF THE COMPLAINT LOT. TESTING MET ACCEPTANCE CRITERIA AND THE PRODUCT IS PERFORMING AS EXPECTED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NONCONFORMANCES, OR DEVIATIONS WITH LOT NUMBER AND THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE. BASED ON THIS INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ALINITY I FREE T4 REAGENT, LOT NUMBER 79271UD01.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 RESULTS GENERATED ON AN ALINITY I PROCESSING MODULE FOR THREE PATIENTS. THE FOLLOWING INFORMATION WAS PROVIDED (FREE T4 REFERENCE RANGE 9.01-19.05 PMOL/L): SAMPLE A SID (B)(6) 55-YEAR-OLD FEMALE, CLINICAL DIAGNOSIS: LUNG CANCER. (B)(6) 2026 INITIAL RESULT = 22.32 PMOL/L, RETEST RESULT = 14.99 PMOL/L. FREE T3 = 4.43 PMOL/L (REFERENCE RANGE: 2.43 - 6.01 PMOL/L). TSH = 0.673 IU/ML (REFERENCE RANGE 0.35 - 4.94 IU/ML). SAMPLE B SID (B)(6) 26-YEAR-OLD MALE, CLINICAL DIAGNOSIS: THYROID CANCER. (B)(6) 2026 INITIAL RESULT = 21.01 PMOL/L, REPEAT RESULT = 18.60 PMOL/L. FREE T3 = 4.70 PMOL/L (REFERENCE RANGE: 2.43 - 6.01 PMOL/L). TSH = 0.058 IU/ML (REFERENCE RANGE: 0.35 - 4.94 IU/ML). SAMPLE C SID (B)(6) 73-YEAR-OLD FEMALE, CLINICAL DIAGNOSIS: RENAL CELL CARCINOMA. (B)(6) 2026 INITIAL RESULT = 27.64 PMOL/L, REPEAT RESULT = 14.79 PMOL/L. FREE T3 RESULT = 4.75 PMOL/L (REFERENCE RANGE: 2.43-6.01 PMOL/L). TSH = 12.318 IU/ML (REFERENCE RANGE: 0.35 - 4.94 IU/ML). THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ADDITIONAL INFORMATION FOR SECTION A: SAMPLE A SID (B)(6), 55-YEAR-OLD FEMALE, SAMPLE B SID (B)(6), 26-YEAR-OLD MALE, SAMPLE C SID (B)(6), 73-YEAR-OLD FEMALE. ADDITIONAL INFORMATION FOR SECTION B3: THE DATE OF EVENT FOR SID (B)(6) IS 01/09/2026.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 RESULTS GENERATED ON AN ALINITY I PROCESSING MODULE FOR THREE PATIENTS. THE FOLLOWING INFORMATION WAS PROVIDED (FREE T4 REFERENCE RANGE 9.01-19.05 PMOL/L): SAMPLE A SID (B)(6), 55-YEAR-OLD FEMALE, CLINICAL DIAGNOSIS: LUNG CANCER ON (B)(6) 2026 INITIAL RESULT = 22.32 PMOL/L, RETEST RESULT = 14.99 PMOL/L FREE T3 = 4.43 PMOL/L (REFERENCE RANGE: 2.43 - 6.01 PMOL/L) TSH = 0.673 IU/ML (REFERENCE RANGE 0.35 - 4.94 IU/ML). SAMPLE B SID(B)(6), 26-YEAR-OLD MALE, CLINICAL DIAGNOSIS: THYROID CANCER ON (B)(6) 2026 INITIAL RESULT = 21.01 PMOL/L, REPEAT RESULT = 18.60 PMOL/L FREE T3 = 4.70 PMOL/L (REFERENCE RANGE: 2.43 - 6.01 PMOL/L) TSH = 0.058 IU/ML (REFERENCE RANGE: 0.35 - 4.94 IU/ML). SAMPLE C SID (B)(6), 73-YEAR-OLD FEMALE, CLINICAL DIAGNOSIS: RENAL CELL CARCINOMA ON (B)(6) 2026 INITIAL RESULT = 27.64 PMOL/L, REPEAT RESULT = 14.79 PMOL/L FREE T3 RESULT = 4.75 PMOL/L (REFERENCE RANGE: 2.43-6.01 PMOL/L) TSH = 12.318 IU/ML (REFERENCE RANGE: 0.35 - 4.94 IU/ML). THERE WAS NO IMPACT TO PATIENT MANAGEMENT.