ELECSYS FT4 IV
Received Apr 27, 2026
Report 1823260-2026-01651 · MDR key 25002384
Device
Generic name
Free Thyroxine
Manufacturer
Roche DiagnosticsModel number
FT4 IVCatalog number
09043276190
Lot number
857243
Product problems
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION ABOUT QUESTIONABLE RESULTS FOR 1 PATIENT TESTED FOR ELECSYS FT4 IV ON A COBAS E411 IMMUNOASSAY ANALYZER (DISK SYSTEM) AND ON A COBAS E801 IMMUNOASSAY ANALYZER WHEN COMPARED TO THE ABBOTT ASSAY. 2. PATIENT AGE RANGE: ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.
Additional Manufacturer Narrative
1. SUMMARY OF INVESTIGATION RESULTS: TWO SAMPLES WERE RECEIVED FOR INVESTIGATION ON 11-FEB-2026. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: THE INVESTIGATION IS ONGOING. 3. DEVICE RETURNED TO MANUFACTURER? NO. 4. DEVICE LABELED "FOR SINGLE USE?" NO. 5. DEVICE REPROCESSED AND REUSED? NO.