ELECSYS CEA
Received Jul 2, 2026 · Event occurred Jun 10, 2026
Report 1823260-2026-02677 · MDR key 25695193
Device
Generic name
Carcinoembryonic Antigen Test System
Manufacturer
Roche DiagnosticsCatalog number
07027079190
Lot number
910862
Product problems
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS CEA RESULT FOR 1 PATIENT ON A COBAS E 402 ANALYTICAL UNIT. THE INITIAL RESULT OF THE PATIENT'S FIRST SAMPLE TUBE WAS 305 NG/ML. THE REPEAT RESULT WAS 2.68 NG/ML. THE RESULT FROM THE PATIENT'S SECOND SAMPLE TUBE WAS 2.65 NG/ML. THE RESULT FROM THE PATIENT'S UNSPECIFIED SAMPLE TUBE WAS 2.74 NG/ML. THE SAMPLE WAS REPEATED AFTER THE DOCTOR QUESTIONED THE INITIAL RESULT. THE REPEAT RESULT WAS DEEMED CORRECT.
Additional Manufacturer Narrative
THE COBAS E 402 ANALYTICAL UNIT SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.