ALINITY I FREE T4 REAGENT KIT

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. COMPLETE INFORMATION FOR SECTION A1 PATIENT IDENTIFIER WAS UPDATED FROM NI TO MULTIPLE AS THE CUSTOMER OBSERVED SIMILAR ISSUE ON 3 ADDITIONAL PATIENT SAMPLES. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED; NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 ON A PATIENT THAT WERE NOT REPORTED TO THE MEDICAL PROVIDER. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE WAS 9.00-19.05 PMOL/L): INITIAL RESULT = > 64.35 PMOL/L, REPEAT RESULT = 15.52 PMOL/L. ADDITIONAL INFORMATION WAS PROVIDED ON (B)(6) 2025. SID 1: INITIAL RESULT = 20.16 PMOL/L, REPEAT RESULTS 13.28 PMOL/L. SID 2; INITIAL RESULT=>64.35 PMOL/L, REPEAT RESULTS 13.74 PMOL/L. ADDITIONAL INFORMATION WAS PROVIDED ON (B)(6) 2025 INITIAL RESULT=>64.35 PMOL/L, REPEAT RESULTS 13.49 PMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

D4 - PRIMARY UDI NUMBER UPDATED. THE COMPLAINT INVESTIGATION FOR FALSELY ELEVATED ALINITY I FREE T4 RESULTS INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, THE REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELING, DEVICE HISTORY RECORDS, AND TESTING OF RETAINED REAGENT KIT. ACCURACY TESTING WAS PERFORMED USING PANELS, WHICH MIMICS PATIENT SAMPLES, AND AN IN-HOUSE RETAINED REAGENT LOT KIT, STORED AT THE RECOMMENDED STORAGE CONDITION. TESTING MET ACCEPTANCE CRITERIA, AND THE PRODUCTS ARE PERFORMING AS EXPECTED. 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 REAGENT LOT. HOWEVER, TESTING WAS PERFORMED UTILIZING A RETAINED KIT OF LOT 75641UD00, WHICH CONTAINS THE SAME BULK MATERIAL AS LOT NUMBER 75641UD01, AND NOTED THAT ALL TESTING PASSED, INDICATING THE REAGENT LOT IS PERFORMING AS EXPECTED. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS FOR THE REAGENT LOT AND COMPLAINT ISSUE. MANUFACTURING DOCUMENTATION FOR THE REAGENT LOT WAS REVIEWED AND DID NOT IDENTIFY ANY ISSUES. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INFORMATION PROVIDED AND ABBOTT DIAGNOSTICS¿ COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF ALINITY I FREE T4, LOT NUMBER 75641UD01, WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 ON A PATIENT THAT WERE NOT REPORTED TO THE MEDICAL PROVIDER. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE WAS 9.00-19.05 PMOL/L): INITIAL RESULT = > 64.35 PMOL/L, REPEAT RESULT = 15.52 PMOL/L. ADDITIONAL INFORMATION WAS PROVIDED ON 11/03/2025 SID 1: INITIAL RESULT = 20.16 PMOL/L, REPEAT RESULTS 13.28 PMOL/L SID 2; INITIAL RESULT=>64.35 PMOL/L, REPEAT RESULTS 13.74 PMOL/L ADDITIONAL INFORMATION WAS PROVIDED ON 11/07/2025 INITIAL RESULT=>64.35 PMOL/L, REPEAT RESULTS 13.49 PMOL/L THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. 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 ON A PATIENT THAT WERE NOT REPORTED TO THE MEDICAL PROVIDER. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE WAS 9.00-19.05 PMOL/L): INITIAL RESULT = > 64.35 PMOL/L, REPEAT RESULT = 15.52 PMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.