ALINITY I FREE T4 REAGENT KIT
Received May 22, 2026 · Event occurred May 14, 2026
Report 3005094123-2026-00242 · MDR key 25256048
Device
Generic name
Radioimmunoassay, Free Thyroxine
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07P70-77
Lot number
82597UD01
Product problems
- High Test Results
Patient
75 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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 FOR A 75-YEAR-OLD FEMALE. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 11-17.7 PMOL/L): SID (B)(6) INITIAL FREE T4 RESULT= 64.35 PMOL/L; CURRENT RESULT= 15.62 PMOL/L; REPEAT RESULT= 15.62 PMOL/L . THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.