ELECSYS FT3 III
Received Apr 27, 2026
Report 1823260-2026-01642 · MDR key 25002174
Device
Generic name
Total Triiodothyronine
Manufacturer
Roche DiagnosticsModel number
FT3 IIICatalog number
09005803190
Lot number
84583803
Product problems
- High Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: DUE TO INSUFFICIENT INFORMATION, THE INVESTIGATION COULD NOT IDENTIFY A SPECIFIC CAUSE OF THE EVENT. 3. DEVICE RETURNED TO MANUFACTURER? NO. 4. DEVICE LABELED "FOR SINGLE USE?"? NO. 5. DEVICE REPROCESSED AND REUSED? NO.
Description of Event or Problem
1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 602 MODULE. 2. PATIENT AGE RANGE: ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: MALE. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.