ELECSYS ESTRADIOL III ASSAY
Received Jun 17, 2026 · Event occurred May 28, 2026
Report 1823260-2026-02417 · MDR key 25537211
Device
Generic name
Radioimmunoassy, Estradiol
Manufacturer
Roche DiagnosticsCatalog number
06656021190
Lot number
906980
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- High Test Results
- Low Test Results
- Non Reproducible Results
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE E411 ANALYZER SERIAL NUMBER WAS (B)(6). THE FIELD SERVICE ENGINEER (FSE) CHECKED AND PRIMED THE SAMPLE/REAGENT PROBE, AND NO BUBBLES WERE IDENTIFIED ON THE SYRINGE NIPPLES. LIQUID FLOW CLEANING (LFC) AND MEASURING CELL (MC) PREPARATION WAS PERFORMED. THE FSE REPEATED THE PATIENT SAMPLE WITH QUESTIONABLE RESULTS, AND THE RESULTS WERE REPRODUCIBLE. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS ESTRADIOL III ASSAY (ESTRADIOL III) ON A COBAS E 411 ANALYZER (DISK SYSTEM). THE INITIAL RESULT WAS 933.8 PMOL/L. THE SAMPLE WAS REPEATED TWICE, WITH RESULTS OF 668.2 PMOL/L AND 981.3 PMOL/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.