ALINITY I FREE T4 REAGENT KIT

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 DID IDENTIFY AN INCREASE IN COMPLAINTS FOR LIST NUMBER 07P70, HOWEVER, NO TRENDS WERE IDENTIFIED FOR LOT COMPLAINT LOT. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT ASSAY AND 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 80419UD00.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I FREE T4 RESULT GENERATED BY THE ALINITY I PROCESSING MODULE FOR A 75-YEAR-OLD FEMALE PATIENT. UPON REPEAT TESTING, THE SAMPLE YIELDED A NORMAL RESULT. IT WAS ALSO NOTED THAT THE PATIENT¿S THYROID RESULTS HAVE BEEN WITHIN NORMAL RANGES FOR THE PAST THREE YEARS. THE FOLLOWING DATA WERE PROVIDED: LAB¿S NORMAL RANGE: 0.70 TO 1.48 NG/DL SID (B)(6): (B)(6) 2026 INITIAL ALINITY I FREE T4 RESULT = >5.00 NG/DL REPEAT RESULT ON ANOTHER INSTRUMENT (B)(6) = 1.33 NG/DL 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. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED, NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I FREE T4 RESULT GENERATED BY THE ALINITY I PROCESSING MODULE FOR A 75-YEAR-OLD FEMALE PATIENT. UPON REPEAT TESTING, THE SAMPLE YIELDED A NORMAL RESULT. IT WAS ALSO NOTED THAT THE PATIENT¿S THYROID RESULTS HAVE BEEN WITHIN NORMAL RANGES FOR THE PAST THREE YEARS. THE FOLLOWING DATA WERE PROVIDED: LAB¿S NORMAL RANGE: 0.70 TO 1.48 NG/DL. SID (B)(6): (B)(6) 2026 INITIAL ALINITY I FREE T4 RESULT = >5.00 NG/DL REPEAT RESULT ON ANOTHER INSTRUMENT (B)(6) = 1.33 NG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.