ARCHITECT FREE T4
Received Apr 1, 2026 · Event occurred Mar 27, 2026
Report 3005094123-2026-00155 · MDR key 24758288
Device
Generic name
Radioimmunoassay, Free Thyroxine
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07K65-78
Lot number
77458UD03
Product problems
- High Test Results
Patient
NA · 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 I2000 ANALYZER FOR 2 PATIENTS. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE: 11-17.7 PMOL/L): TESTING WAS COMPLETED ON (B)(6) 2026: SID (B)(6) (FEMALE, 30 YEARS-OLD): INITIAL RESULT = 33.23 PMOL/L; REPEAT RESULT = 10.74 PMOL/L SID (B)(6) (FEMALE, 31 YEARS-OLD): INITIAL RESULT = 18.01 PMOL/L; REPEAT RESULT = 13.8 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.
Description of Event or Problem
ON (B)(6) 2026, THE CUSTOMER PROVIDED AN ADDITIONAL PATIENT WITH A FALSELY ELEVATED ARCHITECT FREE T4 (FT4) RESULT. THE PATIENT SAMPLE GENERATED AN INITIAL FT4 RESULT OF 30.18 PMOL/L AND THE REPEAT RESULT OF 13.59 PMOL/L. THE PATIENT IS A 33-YEAR-OLD FEMALE. 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. UPDATED SECTION B5 WITH ADDITIONAL PATIENT INFORMATION.