ELECSYS CORTISOL II
Received Jan 12, 2026 · Event occurred Dec 20, 2025
Report 1823260-2026-00140 · MDR key 24038706
Device
Generic name
Fluorometric, Cortisol
Manufacturer
Roche DiagnosticsCatalog number
07027150190
Lot number
85589101
Product problems
- Low Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE ANALYZER IS (B)(4). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS CORTISOL II ASSAY RESULT FOR 1 PATIENT SAMPLE TESTED ON A COBAS E 402 ANALYTICAL UNIT. THE INITIAL RESULT WAS 9.22 UG/L. THE SAMPLE WAS REPEATED TWICE, WITH RESULTS OF 252 UG/L AND 258 UG/L.
Additional Manufacturer Narrative
THE QC WAS WITHIN RANGE BEFORE THE SAMPLE MEASUREMENT. THE SYSTEM WAS RELEASED FOR SAMPLE MEASUREMENT. NO RELEVANT ALARMS OCCURRED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.