Elecsys T3
Received Jul 29, 2026
Report 1823260-2026-03074 · MDR key 50072052
Device
Generic name
Radioimmunoassay, Total Triiodothyronine
Manufacturer
Roche DiagnosticsModel number
T3Catalog number
09007733190
Lot number
893965
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
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 T3 on a cobas e 801 analytical unit.- 2 patient samples for Elecsys T3 on a cobas e 801 analytical unit compared to an Alinity analyzer and an Architect 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
For both events:1. Summary of investigation results: The investigation is ongoing.2. Summary of follow-up/corrective actions taken: The patient sample was requested for investigation.3. Device returned to manufacturer? No.4. Device labeled "for single use?" No.5. Device reprocessed and reused? No.