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, FIELD DATA REVIEW, AND IN-HOUSE TESTING. THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A SEARCH FOR SIMILAR COMPLAINTS IDENTIFIED AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 70400UD00. ADDITIONALLY, A REVIEW OF TRACKING AND TRENDING DATA FOR THE ALINITY I FREE T4 ASSAY IDENTIFIED 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 WITH LOT NUMBER 70400UD00 AND THE COMPLAINT ISSUE. REVIEW OF INSTRUMENT DATA REPORTS SHOWS THAT THE MEDIAN PATIENT RESULT FOR THE MASTER LOT FALLS WITHIN +/-3SD OF THE ESTABLISHED BASELINE, INDICATING THE REAGENT LOT IS PERFORMING ACCEPTABLY ON MARKET. 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 70400UD00. 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 GENERATED FOR PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE 9.01-19.05 PMOL/L): SAMPLE ID (B)(6) (19-YEAR-OLD FEMALE) (B)(6) 2025 INITIAL RESULT = 24.4 PMOL/L, (B)(6) 2025 CENTRIFUGED SAME SAMPLE AND RESULT WITH LOT 71598UD00 = 15.3 PMOL/L. SAMPLE ID (B)(6) (51-YEAR-OLD MALE) (B)(6) 2025 INITIAL RESULT = 27.0 PMOL/L, CENTRIFUGED SAME SAMPLE AND RESULT = 14.7 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 PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE 9.01-19.05 PMOL/L): SAMPLE ID(B)(6), (19-YEAR-OLD FEMALE) (B)(6) 2025 INITIAL RESULT = 24.4 PMOL/L, (B)(6) 2025 CENTRIFUGED SAME SAMPLE AND RESULT WITH LOT 71598UD00 = 15.3 PMOL/L. SAMPLE ID (B)(6), (51-YEAR-OLD MALE) (B)(6) 2025 INITIAL RESULT = 27.0 PMOL/L, CENTRIFUGED SAME SAMPLE AND RESULT = 14.7 PMOL/L . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.