ARCHITECT FREE T4
Received Apr 23, 2026 · Event occurred Apr 14, 2026
Report 3005094123-2026-00190 · MDR key 24968668
Device
Generic name
Radioimmunoassay, Free Thyroxine
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07K65-78
Lot number
80039UD03
Product problems
- High Test Results
Patient
32 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT FREE T4 RESULTS GENERATED ON THE ARCHITECT I2000SR ANALYZER FOR MULTIPLE PATIENTS. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE: 11-17.7 PMOL/L): ON (B)(6) 2026, SID (B)(6) (32-YEAR-OLD, FEMALE): INITIAL FT4 RESULT = 20.44 PMOL/L. REPEAT FT4 RESULT = 9.3 PMOL/L. 2ND REPEAT RESULT = 9.76 PMOL/L. ON (B)(6) 2026, SID (B)(6) (32-YEAR-OLD, FEMALE): INITIAL FT4 RESULT = 26.69 PMOL/L. REPEAT RESULT = 11.77 PMOL/L THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
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 07K65-78 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7K65, WITH 510K/PMA/BLA NUMBER K173122.