ELECSYS CEA
Received Jan 20, 2026 · Event occurred Dec 2, 2025
Report 1823260-2026-00203 · MDR key 24113385
Device
Generic name
Carcinoembryonic Antigen Test System
Manufacturer
Roche DiagnosticsCatalog number
07027079214
Lot number
84013501
Product problems
- High Test Results
- Low Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS CEA ASSAY RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS <0.300 NG/ML WITH A DATA FLAG. THE REPEAT RESULT WAS 2.43 NG/ML WITH A DATA FLAG. THE REPEAT RESULT WAS DEEMED CORRECT.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE CUSTOMER'S COBAS E 801 ANALYTICAL UNIT IS (B)(6). THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
THE INVESTIGATION INCLUDED A REVIEW OF THE DATA SET PROVIDED BY THE CUSTOMER: THE CALIBRATION RESULTS WERE WITHIN THE SPECIFIED RANGES. THE QC RESULTS WERE WITHIN THE SPECIFIED RANGES. THE ALARM TRACE DID NOT INDICATE ANY ISSUES. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.