ELECSYS CEA
Received Jan 12, 2026 · Event occurred Dec 18, 2025
Report 1823260-2026-00132 · MDR key 24035754
Device
Generic name
Carcinoembryonic Antigen Test System
Manufacturer
Roche DiagnosticsCatalog number
07027079190
Lot number
85067002
Product problems
- High Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE QC WAS ACCEPTABLE. A GENERAL REAGENT ISSUE WAS EXCLUDED. THE ALARM TRACE SHOWED "SAMPLE FOAM DETECTION" AND "SAMPLE CLOT DETECTION" ALARMS. THE FIELD SERVICE REPRESENTATIVE FOUND SOME CRYSTALLIZATION ON THE OUTER WALL OF THE PRE-WASHED PROBE. HE FIXED THE ISSUE. THE INVESTIGATION DETERMINED THE ISSUE WAS DUE TO IMPROPER CUSTOMER MAINTENANCE.
Additional Manufacturer Narrative
E1 INITIAL REPORTER ESTABLISHMENT NAME: (B)(6). THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS CEA RESULT FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 10.8 NG/L, AND THE REPEATED RESULTS WERE 2.85 NG/ML AND 2.90 NG/L. THE REPEATED RESULT OF 2.90 NG/L WAS BELIEVED TO BE CORRECT. THE SAMPLE WAS REPEATED BECAUSE THE INITIAL RESULT DIDN'T MATCH THE PATIENT'S CLINICAL DIAGNOSIS. THE PATIENT'S CLINICAL DIAGNOSIS WAS NOT PROVIDED.