ELECSYS HE4
Received Mar 18, 2026 · Event occurred Feb 25, 2026
Report 1823260-2026-00983 · MDR key 24628416
Device
Generic name
Human Epididymis Protein 4 (he4) Ivd, Kit, Chemiluminescent Immunoassay
Manufacturer
Roche DiagnosticsCatalog number
07027478190
Lot number
84981601
Product problems
- High Test Results
- Low Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HE4 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 15.0 PMOL/L WITH FLAG. THE RESULT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS WHICH PROMPTED THE CUSTOMER TO REPEAT THE SAMPLE. THE REPEAT RESULT WAS 73.9 PMOL/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.
Additional Manufacturer Narrative
THE QC RECOVERY DATA PROVIDED WAS WITHIN SPECIFICATION. BASED ON THE QC DATA, A GENERAL REAGENT ISSUE COULD BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.