ALINITY I FREE T4 REAGENT KIT
Received Apr 3, 2026 · Event occurred Mar 17, 2026
Report 3005094123-2026-00156 · MDR key 24777520
Device
Generic name
Radioimmunoassay, Free Thyroxine
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07P70-30
Lot number
79271UD00
Product problems
- High Test Results
Patient
48 YR · Female
- 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.
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 RESULTS FOR A 48-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE 9-23 PMOL/L): SID (B)(6). FT4 32.43 PMOL/L (B)(6) 2026, FT4 14.58 PMOL/L (B)(6) 2025, FT4 14.20 PMOL/L (B)(6) 2026, NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.