ELECSYS CEA
Received Dec 21, 2025 · Event occurred Nov 29, 2025
Report 1823260-2025-05258 · MDR key 23860433
Device
Generic name
Carcinoembryonic Antigen Test System
Manufacturer
Roche DiagnosticsCatalog number
07027079190
Lot number
85067001
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 SERIAL NUMBER OF THE E 801 ANALYZER IS (B)(6). CALIBRATION SIGNALS WERE LOWER THAN EXPECTED. QUALITY CONTROLS WERE WITHIN RANGE; THEREFORE, A REAGENT OR ANALYZER ISSUE CAN BE RULED OUT. NO RELEVANT ALARMS WERE OBSERVED ON THE DAY OF THE EVENT. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS CEA ON A COBAS E 801 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN A CEA VALUE OF 135 NG/ML. NEW SAMPLES COLLECTED FROM THE PATIENT WERE TESTED FOR CEA AT DIFFERENT LABORATORIES ON BOTH ROCHE AND COMPETITOR SYSTEMS AND THE RESULTS WERE WITHIN EXPECTED REFERENCE RANGES. SPECIFIC RESULTS COULD NOT BE PROVIDED. THE COMPLAINED SAMPLE WAS REPEATED ON (B)(6) 2025, RESULTING IN A CEA VALUE OF 1.42 NG/ML. THE REPEAT VALUE WAS DEEMED CORRECT BY THE PHYSICIAN.
Additional Manufacturer Narrative
THE INVESTIGATION DETERMINED THE ISSUE IS CONSISTENT WITH INSUFFICIENT PRE-ANALYTIC SAMPLE HANDLING.