ELECSYS CA 19-9
Received Feb 12, 2026 · Event occurred Jan 19, 2026
Report 1823260-2026-00497 · MDR key 24322363
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
Additional Manufacturer Narrative
THE COBAS E 801 MODULE SERIAL NUMBER IS (B)(6).
Description of Event or Problem
THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS CA 19-9 RESULTS FROM SOME PATIENT SAMPLES TESTED ON THE COBAS E 801 MODULE. ONE EXAMPLE OF DISCREPANT RESULTS WAS PROVIDED: THE INITIAL RESULT IS 50 U/ML. THE FIRST REPEAT RESULT WAS "10 OR LESS U/ML". THE SECOND REPEAT RESULT WAS "10 OR LESS U/ML". THE REPEAT RESULTS WERE DEEMED CORRECT.
Additional Manufacturer Narrative
CONTROLS WERE ACCEPTABLE PRIOR TO THE EVENT. A GENERAL REAGENT ISSUE CAN BE RULED OUT. ISOLATED NON-REPRODUCIBLE RESULTS DO NOT REPRESENT A GENERAL MALFUNCTION OF THE ASSAY. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. A REVIEW OF ALARM TRACE DATA SHOWED NO RELEVANT ALARMS.