ELECSYS T3
Received Jan 26, 2026
Report 1823260-2026-00282 · MDR key 24183981
Device
Generic name
Total Triiodothyronine Test
Manufacturer
Roche DiagnosticsModel number
T3Catalog number
09007725190
Lot number
ASKU
Product problems
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
1. THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS T3 RESULTS FOR ONE PATIENT FROM THE COBAS E411 RACK ANALYZER. 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: THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. AS NO SAMPLE MATERIAL WAS AVAILABLE, FURTHER INVESTIGATION WAS NOT POSSIBLE. 2. SUMMARY OF FOLLOW-UP/CORRECTIVE ACTIONS TAKEN: THERE WERE NO FOLLOW-UP/CORRECTIVE ACTIONS. 3. DEVICE RETURNED TO MANUFACTURER? NO. 4. DEVICE LABELED "FOR SINGLE USE?" NO. 5. DEVICE REPROCESSED AND REUSED? NO.