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.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I FREE T4 GENERATED FROM ALINITY I PROCESSING MODULE (SN: (B)(6)). THE CUSTOMER PROVIDED THE FOLLOWING DATA: ON (B)(6) 2025, SAMPLE ID (B)(6), INITIAL RESULT WAS 23.8 PMOL/L AND REPEAT RESULTS WERE 18.9 & 17.2 PMOL/L. ON (B)(6) 2025, THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND THE RESULT VALUE THAT WAS GENERATED WAS 13.4 PMOL/L. CUSTOMER REFERENCE RANGE IS 9.0 TO 19.0 PMOL/L. PER THE CUSTOMER THE DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE PATIENT¿S MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND IN HOUSE TESTING. 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 DID IDENTIFY AN INCREASE IN COMPLAINTS FOR THE ALINITY I FREE T4 REAGENT AND FOR THE COMPLAINT LOT 71236UD00. HOWEVER, IN-HOUSE TESTING WAS COMPLETED WHICH CONCLUDED THE COMPLAINT LOT MET ACCEPTANCE CRITERIA, DEMONSTRATING THAT THE LOT IS PERFORMING AS EXPECTED. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY ISSUES WITH THE COMPLAINT LOT. LABELING WAS REVIEWED AND WAS FOUND TO ADDRESS THE CUSTOMER REPORTED ISSUE. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED FOR THE ALINITY I FREE T4 REAGENT LOT 71236UD00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I FREE T4 GENERATED FROM ALINITY I PROCESSING MODULE (SN: (B)(6). THE CUSTOMER PROVIDED THE FOLLOWING DATA: ON (B)(6) 2025, SAMPLE ID (B)(6), INITIAL RESULT WAS 23.8 PMOL/L AND REPEAT RESULTS WERE 18.9 & 17.2 PMOL/L. ON (B)(6) 2025, THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND THE RESULT VALUE THAT WAS GENERATED WAS 13.4 PMOL/L. CUSTOMER REFERENCE RANGE IS 9.0 TO 19.0 PMOL/L. PER THE CUSTOMER THE DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE PATIENT¿S MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.