ARCHITECT FREE T4
Received Jun 23, 2026 · Event occurred Jun 3, 2026
Report 3005094123-2026-00305 · MDR key 25593903
Device
Generic name
Radioimmunoassay, Free Thyroxine
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07K65-39
Lot number
84182UD00
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 GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR MULTIPLE SAMPLES. THE FOLLOWING RESULTS WERE PROVIDED: (CUSTOMER PROVIDED FREE T4 REFERENCE RANGE: 10 - 24 PMOL/L): (B)(6) 2026, SID (B)(6), INITIAL RESULT = 35.3 PMOL/L, REPEAT RESULT = 18.7 PMOL/L; (B)(6) 2026, SID (B)(6), INITIAL RESULT = 27.7 PMOL/L, REPEAT RESULT = 14.9 PMOL/L; (B)(6) 2026, SID (B)(6), INITIAL RESULT = 28.3 PMOL/L, REPEAT RESULT = 21.8 PMOL/L; (B)(6) 2026, SID (B)(6), INITIAL RESULT = 30.4 PMOL/L, REPEAT RESULT = 22.2 PMOL/L; SID (B)(6), INITIAL RESULT = >64.35 PMOL/L, REPEAT RESULT = 22.6 PMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
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.