ARCHITECT FREE T4

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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07K65-77 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7K65, WITH 510K/PMA/BLA NUMBER K173122.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT FREE T4 RESULTS GENERATED ON THE ARCHITECT I2000SR ANALYZER FOR A 46-YEAR-OLD FEMALE PATIENT DIAGNOSED WITH A THYROID NODULE. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2026, PERFORMED THE THYROID FUNCTION 3-PANEL ASSAY: FT4: > 64.35 PMOL/L, ELEVATED (REFERENCE RANGE 9.01-19.05 PMOL/L) THE CUSTOMER RETESTED THE SAMPLE AND GENERATED A RESULT OF > 64.35 PMOL/L AND RELEASED THE RESULT TO THE CLINICAL PHYSICIAN. THE CLINICAL PHYSICIAN QUESTIONED THE RESULT. ON (B)(6) 2026, THE CUSTOMER RE-CENTRIFUGED THE SAMPLE AND RETESTED FREE T4 TWICE. THE SAMPLE GENERATED FREE T4 RESULTS OF 14.21 PMOL/L AND 14.31 PMOL/L (NORMAL). OTHER THYROID FUNCTION TEST RESULTS: TSH: 0.396 UIU/ML, NORMAL (REFERENCE RANGE: 0.350-4.94 UIU/ML) FT3: 4.86 PMOL/L, NORMAL (REFERENCE RANGE 2.43-6.01 PMOL/L) THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.