MalfunctionCEC
ELECSYS FT4 III
Received Aug 12, 2025 · Event occurred Jul 17, 2025
Report 1823260-2025-02450 · MDR key 22786366
Device
Generic name
Radioimmunoassay, Free Thyroxine
Manufacturer
Roche DiagnosticsModel number
FT4Catalog number
07976887190
Lot number
827798
Product problems
- High Test Results
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT4 III RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 2.2 NG/DL. ON (B)(6) 2025, THE REPEATED RESULT WAS 1.26 NG/DL. THE REPEATED RESULT WAS BELIEVED TO BE CORRECT.