MalfunctionJFT
ELECSYS CORTISOL II
Received Jun 24, 2026 · Event occurred Jun 3, 2026
Report 1823260-2026-02496 · MDR key 25606597
Device
Generic name
Fluorometric, Cortisol
Manufacturer
Roche DiagnosticsCatalog number
07027150190
Lot number
922331
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Low Test Results
- Output Problem
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS CORTISOL II ASSAY RESULT FOR A PATIENT SAMPLE TESTED ON THE COBAS PURE E 402 ANALYTICAL UNIT. THE INITIAL RESULT WAS 2.07 NMOL/L. THE REPEAT RESULT WAS 497 NMOL/L.