ELECSYS FT3 III
Received Apr 27, 2026
Report 1823260-2026-01640 · MDR key 25002186
Device
Generic name
Total Triiodothyronine Test
Manufacturer
Roche DiagnosticsModel number
FT3 IIICatalog number
09005811214
Lot number
ASKU
Product problems
- Chemical Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS FT3 III RESULT FOR ONE PATIENT'S SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. 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 DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. 2. SUMMARY OF FOLLOW-UP/CORRECTIVE ACTIONS TAKEN: THE PATIENT SAMPLE IS NOT AVAILABLE FOR INVESTIGATION. 3. DEVICE RETURNED TO MANUFACTURER? NO. 4. DEVICE LABELED "FOR SINGLE USE?"? NO. 5. DEVICE REPROCESSED AND REUSED? NO.