ELECSYS CEA
Received Nov 14, 2025 · Event occurred Oct 25, 2025
Report 1823260-2025-04650 · MDR key 23556586
Device
Generic name
Carcinoembryonic Antigen Test System
Manufacturer
Roche DiagnosticsCatalog number
07027079214
Lot number
ASKU
Product problems
- High Test Results
- Non Reproducible Results
- High Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE ROCHE ANALYZER'S SERIAL NUMBER WAS REQUESTED BUT NOT PROVIDED. A GENERAL REAGENT PROBLEM WAS EXCLUDED, AS THERE ARE NO OTHER REPORTED COMPLAINTS OF THIS MATERIAL. PER LABELING, " CEA VALUES DETERMINED ON PATIENT SAMPLES BY DIFFERENT TESTING PROCEDURES CANNOT BE DIRECTLY COMPARED WITH ONE ANOTHER AND COULD BE THE CAUSE OF ERRONEOUS MEDICAL INTERPRETATION." THE INVESTIGATION WAS UNABLE TO DETERMINE A DIRECT ROOT CAUSE DUE TO THE LIMITED DATA COLLECTED.
Description of Event or Problem
THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS CEA RESULT FROM A NON-SPECIFIED ROCHE ANALYZER FOR ONE PATIENT. THE INITIAL RESULT WAS 4.1 NG/ML. A REPEAT RESULT ON THE SAME ANALYZER WAS 4.5 NG/ML. A RESULT FROM ANOTHER LABORATORY ON ANOTHER UNSPECIFIED ANALYZER WAS APPROXIMATELY 11 NG/ML.