ARCHITECT FREE T4
Received Jul 1, 2026 · Event occurred Jun 22, 2026
Report 3005094123-2026-00324 · MDR key 25681593
Device
Generic name
Radioimmunoassay, Free Thyroxine
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07K65-77
Lot number
82217UD02
Product problems
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT FREE T4 RESULTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): INITIAL FREE T4 TEST 22.04 (REFERENCE RANGE 9.01-19.09), RETESTED FREE T4 13.10. OTHER RESULTS PROVIDED: FREE T3 5.82 (REFERENCE RANGE 2.43-6.01), TSH 1.7038 (REFERENCE RANGE 0.35-4.9). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED, NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.