ALINITY I FREE T4 REAGENT KIT

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I FREE T4 AND PROVIDED THE FOLLOWING DATA FOR 1 PATIENT: ON (B)(6), SAMPLE ID (B)(6), INITIAL RESULT WAS 36.1 PMOL/L. THIS RESULT WAS QUESTIONED BY THE PATIENT¿S PRACTITIONER. ON (B)(6), THE SAMPLE WAS REPEATED AND GENERATED RESULTS OF 17.0 & 17.4 PMOL/L. (CUSTOMER REFERENCE RANGE: 9-19.05 PMOL/L) ADDITIONAL LABORATORY DATA: TSH RESULT: 0.690 MIU/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

SECTION B3 DATE OF EVENT WAS UPDATED FROM 08/29/2025 TO 08/28/2025. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. 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 73465UD00. HOWEVER, TESTING WAS PERFORMED UTILIZING RETAINED KITS OF LOT 73465UD00 AND NOTED THAT ALL TESTING PASSED, INDICATING THE REAGENT LOTS ARE PERFORMING AS EXPECTED. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY ISSUES WITH THE COMPLAINT ASSAY. LABELING WAS REVIEWED AND FOUND TO ADDRESS THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I FREE T4 ASSAY, LOT 73465UD00 WAS IDENTIFIED.

Additional Manufacturer Narrative

A1 PATIENT IDENTIFIER: COMPLETE SAMPLE ID IS (B)(6). 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 AND PROVIDED THE FOLLOWING DATA FOR 1 PATIENT: ON (B)(6) SAMPLE ID (B)(6) INITIAL RESULT WAS 36.1 PMOL/L. THIS RESULT WAS QUESTIONED BY THE PATIENT¿S PRACTITIONER. ON (B)(6), THE SAMPLE WAS REPEATED AND GENERATED RESULTS OF 17.0 & 17.4 PMOL/L. (CUSTOMER REFERENCE RANGE: 9-19.05 PMOL/L). ADDITIONAL LABORATORY DATA: TSH RESULT: 0.690 MIU/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.