ELECSYS CEA
Received Jan 15, 2026 · Event occurred Dec 18, 2025
Report 1823260-2026-00184 · MDR key 24082479
Device
Generic name
Carcinoembryonic Antigen Test System
Manufacturer
Roche DiagnosticsCatalog number
07027079190
Lot number
850670
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 6.86 NG/ML. THE REPEAT RESULT WAS 1.25 NG/ML. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY, AS IT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS.
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 ASSAY WAS LAST CALIBRATED ON (B)(6) 2025, AND THE RESULTS WERE WITHIN THE SPECIFIED RANGES. PRODUCT LABELING STATES: "RENEWED CALIBRATION IS RECOMMENDED AS FOLLOWS: AFTER 12 WEEKS WHEN USING THE SAME REAGENT LOT. AFTER 28 DAYS WHEN USING THE SAME COBAS E PACK ON THE ANALYZER. AS REQUIRED: E.G. QUALITY CONTROL FINDINGS OUTSIDE THE DEFINED LIMITS." THE QC RESULTS WERE WITHIN THE SPECIFIED RANGES. THERE WAS NO INDICATION OF A PERFORMANCE ISSUE WITH THE REAGENT. THE ALARM TRACE DID NOT INDICATE ANY ISSUES. A GENERAL REAGENT PROBLEM WAS NOT DETECTED BECAUSE THE QCS BEFORE THE EVENT WERE WITHIN THE SPECIFIED RANGES. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.