ELECSYS CALCITONIN
Received Mar 25, 2026 · Event occurred Mar 5, 2026
Report 1823260-2026-01087 · MDR key 24689964
Device
Generic name
Calcitonin Test System
Manufacturer
Roche DiagnosticsCatalog number
09005676190
Lot number
83695701
Product problems
- Low Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS E 402 ANALYTICAL UNIT SERIAL NUMBER IS (B)(6). THE SAMPLE HAS BEEN REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS CALCITONIN RESULT FROM THE COBAS E 402 ANALYTICAL UNIT FOR ONE PATIENT. THE PATIENT'S FIRST RESULT WITH THE COBAS E 402 WAS 1.3 NG/L. THE RESULT WITH THE DIASORIN LIAISON XL WAS 50.3 NG/L. THE PATIENT'S RESULT 4 MONTHS LATER ON THE COBAS E 402 WAS 0.9 NG/L. THE RESULT WITH THE DIASORIN LIAISON XL WAS 28.6 NG/L.