ELECSYS PROLACTIN ASSAY
Received Jul 17, 2026 · Event occurred Jun 13, 2026
Report 1823260-2026-02914 · MDR key 25857171
Device
Generic name
Radioimmunoassay, Prolactin (lactogen)
Manufacturer
Roche DiagnosticsCatalog number
03203093190
Lot number
ASKU
Product problems
- High Test Results
- Low Test Results
- Non Reproducible Results
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS PROLACTIN ASSAY RESULTS FROM THE COBAS E411 RACK ANALYZER.THE CUSTOMER PREVIOUSLY USED THE UNIT OF MEASURE NG/ML. THE TEST UNIT WAS CHANGED TO IU/ML AT THE REQUEST OF SPECIALIST DOCTORS.A PATIENT SAMPLE HAD A RESULT OF 419.30 IU/ML, WHICH, ACCORDING TO THIS UNIT'S EXPECTED REFERENCE RANGES (102-496) WAS CONSIDERED NORMAL. THIS RESULT CONVERTS TO 19.7071 NG/ML.WHEN THE SAME SAMPLE WAS ANALYZED USING THE NG/ML TEST UNIT, IT RESULTED IN 46.02 NG/ML, WHICH, ACCORDING TO THIS UNIT, WAS OUTSIDE THE NORMAL RANGE (4.79-23.3).ON (b)(6) 2026, THE RESULT FROM ANOTHER LABORATORY WAS 10.12 UG/L.ON (b)(6) 2026, THE SAME SAMPLE WAS REPEATED, AND THE RESULT WAS 16.06 NG/ML.
Additional Manufacturer Narrative
THE COBAS E411 RACK ANALYZER SERIAL NUMBER WAS 8985-16.QUALITY CONTROL AND CALIBRATION WERE PERFORMED AFTER THE UNIT CHANGE.THE INVESTIGATION IS ONGOING.