ELECSYS FT4
Received Jul 24, 2025
Report 1823260-2025-02263 · MDR key 22587302
Device
Generic name
Free Thyroxine
Manufacturer
Roche DiagnosticsModel number
FT4 IVCatalog number
ASKU
Lot number
ASKU
Product problems
- False Positive Result
- False Positive Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION IS ONGOING. 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.
Description of Event or Problem
1. THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT4 RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT.
Additional Manufacturer Narrative
1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION DETERMINED THE ISSUE WAS DUE TO PRE-ANALYTICAL HANDLING ISSUES AT THE CUSTOMER SITE. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY. THERE IS NO EVIDENCE TO SUGGEST A MALFUNCTION OF THE DEVICE. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: NONE.