ELECSYS CA 19-9
Received May 28, 2026 · Event occurred May 11, 2026
Report 1823260-2026-02104 · MDR key 25313898
Device
Generic name
Test, Carbohydrate Antigen (ca19-9)
Manufacturer
Roche DiagnosticsCatalog number
07027028188
Lot number
86153802
Product problems
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE E 801 ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING. MEDWATCH FIELD E1 INITIAL REPORTER EMAIL ADDRESS - THE EMAIL ADDRESS WAS PROVIDED AS "(B)(6)".
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS CA 19-9 ON A COBAS E 801 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN A CA 19-9 VALUE OF 97.6 U/ML. THE RESULT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS, SO THE SAMPLE WAS REPEATED. THE REPEAT CA 19-9 RESULT WAS 16.8 U/ML. THE SAMPLE WAS ALSO REPEATED ON (B)(6) 2026, RESULTING IN A VALUE OF 17.1 U/ML.