ELECSYS CA 19-9
Received Apr 17, 2026 · Event occurred Mar 23, 2026
Report 1823260-2026-01465 · MDR key 24910220
Device
Generic name
Test, Carbohydrate Antigen (ca19-9)
Manufacturer
Roche DiagnosticsCatalog number
07027028214
Lot number
86153801
Product problems
- High 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 CA 19-9 RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 MODULE. THE INITIAL RESULT IS 77.6 U/ML. THE FIRST REPEAT RESULT IS 46.2 U/ML. THE SECOND REPEAT RESULT IS 46.9 U/ML. THE THIRD REPEAT RESULT IS 48.4 U/ML. THE SECOND REPEAT RESULT WAS REPORTED TO THE CLINICIANS.
Additional Manufacturer Narrative
THE COBAS E 801 MODULE SERIAL NUMBER IS (B)(6). THE INVESTIGATION REVIEWED THE MODULE'S ALARM TRACE; NO ISSUES WERE NOTED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.