ALINITY I FREE T4 REAGENT KIT

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 RESULTS GENERATED FOR PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE 9.01-19.05 PMOL/L): SAMPLE ID (B)(6) (47-YEAR-OLD FEMALE): INITIAL RESULT = >64.35 PMOL/L, REPEAT RESULTS = 12.72 PMOL/L, 11.66 PMOL/L. (B)(6) 2025: SAMPLE ID (B)(6) (87-YEAR-OLD FEMALE): INITIAL RESULT = 22.18 PMOL/L, REPEAT RESULT = 16.55 PMOL/L, SAMPLE ID (B)(6) (40-YEAR-OLD MALE): INITIAL RESULT = 19.37 PMOL/L, REPEAT RESULT = 15.64 PMOL/L, SAMPLE ID (B)(6) (36-YEAR-OLD FEMALE): INITIAL RESULT = 20.01 PMOL/L, REPEAT RESULT = 16.95 PMOL/L. ADDITIONAL LABORATORY DATA PROVIDED FOR SAMPLE ID (B)(6): FT3 RESULT = 3.84 PMOL/L (REFERENCE RANGE 2.43-6.01 PMOL/L), TSH RESULT = 2.6451 UIU/ML (REFERENCE RANGE 0.35-4.94 UIU/ML), TPOAB RESULT = 51.13 IU/ML (REFERENCE RANGE 0-5.61 IU/ML), TGAB RESULT = 23.98 IU/ML (REFERENCE RANGE 0-4.11 IU/ML). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL 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 REAGENT LOT 76559UD01. HOWEVER, TESTING WAS PERFORMED UTILIZING RETAINED KITS OF LOT 76559UD00 AND NOTED THAT ALL TESTING PASSED, INDICATING THE REAGENT LOTS ARE PERFORMING AS EXPECTED. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT AND COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE 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. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I FREE T4 ASSAY, LOT 76559UD01 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 RESULTS GENERATED FOR PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE 9.01-19.05 PMOL/L): SAMPLE ID (B)(6) (47-YEAR-OLD FEMALE): INITIAL RESULT = >64.35 PMOL/L, REPEAT RESULTS = 12.72 PMOL/L, 11.66 PMOL/L. ON (B)(6) 2025, SAMPLE ID (B)(6) (87-YEAR-OLD FEMALE): INITIAL RESULT = 22.18 PMOL/L, REPEAT RESULT = 16.55 PMOL/L. SAMPLE ID (B)(6) (40-YEAR-OLD MALE): INITIAL RESULT = 19.37 PMOL/L, REPEAT RESULT = 15.64 PMOL/L. SAMPLE ID (B)(6) (36-YEAR-OLD FEMALE): INITIAL RESULT = 20.01 PMOL/L, REPEAT RESULT = 16.95 PMOL/L. ADDITIONAL LABORATORY DATA PROVIDED FOR SAMPLE ID (B)(6): FT3 RESULT = 3.84 PMOL/L (REFERENCE RANGE 2.43-6.01 PMOL/L), TSH RESULT = 2.6451 UIU/ML (REFERENCE RANGE 0.35-4.94 UIU/ML), TPOAB RESULT = 51.13 IU/ML (REFERENCE RANGE 0-5.61 IU/ML), TGAB RESULT = 23.98 IU/ML (REFERENCE RANGE 0-4.11 IU/ML) . 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). SECTION A2 - AGE AT TIME OF EVENT/A2 - AGE UNITS (PATIENT) /A3A - SEX: SEE SECTION B5 FOR COMPLETE DETAILS. SECTION E1 - INITIAL REPORTER ESTABLISHMENT NAME COMPLETE ENTRY = (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.