ARCHITECT FREE T4
Received Jul 1, 2026 · Event occurred Jun 17, 2026
Report 3005094123-2026-00323 · MDR key 25679447
Device
Generic name
Radioimmunoassay, Free Thyroxine
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07K65-29
Lot number
84185UD00
Product problems
- High Test Results
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. 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 RESULTS FOR ONE MALE PATIENT. THE PATIENT IS UNDERGOING THERAPY WITH EUTIROX. THE FOLLOWING DATA WAS PROVIDED (NORMAL RANGE FREE T4 0.7 TO 1.48 NG/DL): (B)(6) 2026 SID (B)(6) FT4 RESULT >5.00 NG/DL, REPEATED >5.00 NG/DL, OTHER RESULTS PROVIDED: TSH 1.4450 UIU/ML, FREE T3 RESULT 2.92 PG/ML. THE SAMPLE WAS CENTRIFUGED, FROZEN, AND REPEATED THE NEXT DAY AND THE FREE T4 RESULT WAS 1.17 NG/DL. A NEW SAMPLE WAS DRAWN FROM THE PATIENT ON (B)(6) 2026: 2 TUBES WITH SEPARATOR GEL AND 1 TUBE WITHOUT SEPARATOR GEL. THE FOLLOWING RESULTS WERE OBTAINED: SID (B)(6), (GEL TUBE NO. 1) 1.46 NG/DL SID (SURNAME) SE2 (GEL TUBE NO. 2) 1.83 NG/DL SID (SURNAME) NO GEL >5 NG/DL, CENTRIFUGED AND REPEATED 2.70 NG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.