MalfunctionCFT
ELECSYS PROLACTIN ASSAY
Received May 6, 2026 · Event occurred Apr 13, 2026
Report 1823260-2026-01759 · MDR key 25092578
Device
Generic name
Radioimmunoassay, Prolactin (lactogen)
Manufacturer
Roche DiagnosticsCatalog number
03203093190
Lot number
ASKU
Product problems
- Incorrect Measurement
- High Test Results
- Low Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE E411 ANALYZER SERIAL NUMBER WAS (B)(6).
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS PROLACTIN ASSAY (PROLACTIN) ON A COBAS E 411 ANALYZER (DISK SYSTEM). THE INITIAL RESULT WAS 0.087 NG/ML. THE REPEAT RESULT WAS 8.37 NG/ML.