ELECSYS PROLACTIN II
Received Apr 14, 2026 · Event occurred Feb 12, 2026
Report 1823260-2026-01421 · MDR key 24877027
Device
Generic name
Radioimmunoassay, Prolactin (lactogen)
Manufacturer
Roche DiagnosticsCatalog number
07027737190
Lot number
899360
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- High Test Results
Patient
60 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE E801 ANALYZER SERIAL NUMBER WAS (B)(6).
Description of Event or Problem
WE RECEIVED AN ALLEGATION OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS TESTOSTERONE II ASSAY (TESTOSTERONE II), ELECSYS ESTRADIOL III (ESTRADIOL III), AND ELECSYS PROLACTIN II (PROLACTIN II) ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO THE SIEMENS METHOD AND LIQUID CHROMATOGRAPHY¿MASS SPECTROMETRY (LC-MS). THIS MEDWATCH WILL COVER PROLACTIN II. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ESTRADIOL III RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE TESTOSTERONE II RESULTS. THE TESTOSTERONE II RESULT FROM THE E801 ANALYZER WAS 52.0 NMOL/L. THE RESULT FROM THE SIEMENS METHOD WAS 25 NMOL/L. THE LC-MS RESULT WAS 17.7 NMOL/L. THE ESTRADIOL III RESULT FROM THE E801 ANALYZER WAS 474 PMOL/L. THE RESULT FROM THE SIEMENS METHOD WAS 0.16 PMOL/L. THE PROLACTIN II RESULT FROM THE E801 ANALYZER WAS 265 MU/L. THE RESULT FROM THE SIEMENS METHOD WAS 0.17 IU/L.