ALINITY I FREE T4 REAGENT KIT

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 37-YEAR-OLD FEMALE PATIENT, WHICH IS DISCREPANT COMPARED TO THE CHEMCLIN PLATFORM. THE ABBOTT TEST RESULTS WERE NOT SENT TO THE CLINICAL PHYSICIAN. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): (B)(6) 2025 ALINITY I FREE T4 RESULT= 9.95 PMOL/L (REFERENCE RANGE: 9.01 TO 19.05 PMOL/L) CHEMCLIN PLATFORM = 11.53 PMOL/L (REFERENCE RANGE:12 TO 22 PMOL/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ALINITY I FREE T4 REAGENT, LOT 78042UD01 TO ADDRESS THE CUSTOMER¿S OBSERVATION OF FALSELY ELEVATED RESULTS. A REVIEW OF TRACKING AND TRENDING IDENTIFIED AN INCREASE IN COMPLAINTS FOR THE ALINITY I FREE T4 REAGENT AS WELL AS AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 78042UD01. HOWEVER, TESTING WAS PERFORMED UTILIZING RETAINED KITS OF LOT 78042UD01 AND NOTED THAT ALL TESTING PASSED, INDICATING THE REAGENT LOTS ARE PERFORMING AS EXPECTED. A REVIEW IN THE CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) SYSTEM DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCE OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT ASSAY. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ALINITY I FREE T4 REAGENT FOR LOT 78042UD01.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION HAS BEEN INCLUDED. NO ADDITIONAL PATIENT DETAILS ARE AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P70 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07P70, WITH 510K NUMBER K173122.

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 37-YEAR-OLD FEMALE PATIENT, WHICH IS DISCREPANT COMPARED TO THE CHEMCLIN PLATFORM. THE ABBOTT TEST RESULTS WERE NOT SENT TO THE CLINICAL PHYSICIAN. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): ON (B)(6) 2025 ALINITY I FREE T4 RESULT= 9.95 PMOL/L (REFERENCE RANGE: 9.01 TO 19.05 PMOL/L) CHEMCLIN PLATFORM = 11.53 PMOL/L (REFERENCE RANGE:12 TO 22 PMOL/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.