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. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY DECREASED ALINITY I FREE T4 GENERATED FROM ALINITY I PROCESSING MODULE AND PROVIDED THE FOLLOWING DATA: PATIENT 1: ON (B)(6) 2026, SID (B)(6) FREE T4 RESULT WAS 21.88. THE PATIENT'S PHYSICIAN QUESTIONED THIS RESULT AND WHEN THE SAMPLE WAS REPEATED THE RESULT WAS 21.88. (ALINITY REFERENCE RANGE IS: 9.01-19.05 PMOL/L.). WHEN TESTED ON THE SNIBE PLATFORM, THE RESUTLS WERE 33.5 AND 32.5 (SNIBE REFERENCE RANGE: 11.58-22.52 PMOL/L). THE PHYSICIAN CONSIDERS THE FT4 RESULT ON THE SNIBE ANALYZER TO BE MORE CONSISTENT WITH THE PATIENT'S CLINICAL CONDITION. PATIENT INFORMATION: FEMALE; 30 YEARS OLD. DIAGNOSTICS: BRONCHIAL ASTHMA ATTACK/HYPERTHYROIDISM; THE PATIENT IS NOT TAKING ANY MEDICATION. ADDITIONAL LABORATORY DATA PROVIDED: TSH < 0.0083 UIU/ML PATIENT 2: ON (B)(6) 2026, SID (B)(6) FREE T4 RESULT WAS 14.68. THE PATIENT'S PHYSICIAN QUESTIONED THIS RESULT AND WHEN THE SAMPLE WAS REPEATED THE RESULT WAS 14.81. (ALINITY REFERENCE RANGE IS: 9.01-19.05 PMOL/L.). WHEN TESTED ON THE SNIBE PLATFORM, THE RESULT WAS 25.5 (SNIBE REFERENCE RANGE: 11.58-22.52 PMOL/L). THE PHYSICIAN CONSIDERS THE FT4 RESULT ON THE SNIBE ANALYZER TO BE MORE CONSISTENT WITH THE PATIENT'S CLINICAL CONDITION. PATIENT INFORMATION: FEMALE; 23 YEARS OLD. DIAGNOSTICS: HYPERTHYROIDISM. ADDITIONAL LABORATORY DATA PROVIDED: FT3: 4.16 PMOL/L; TSH: 0.0684 UIU/ML THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.