ARCHITECT FREE T4
Received Jun 12, 2026 · Event occurred May 21, 2026
Report 3005094123-2026-00285 · MDR key 25487557
Device
Generic name
Radioimmunoassay, Free Thyroxine
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07K65-29
Lot number
84185UD00
Product problems
- High Test Results
Patient
60 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT FREE T4 FOR A 60-YEAR-OLD MALE. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 0.70NG/DL TO 1.48 NG/DL): (B)(6) 2026, SID (B)(6), INITIAL FREE T4 RESULT= >5 NG/DL (ADDITIONAL RESULT PROVIDED: TSH= 3.279 UIU/ML); (B)(6) 2026, REPEAT RESULTS= 0.92 NG/DL AND 0.98 NG/DL (ADDITIONAL RESULT PROVIDED: TSH= 3.370 UIU/ML); (B)(6) 2026, SID (B)(6) , ANOTHER SAMPLE COLLECTED WITH A RESULT= 1.17 NG/DL THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.