ELECSYS CA 19-9
Received Jan 30, 2026 · Event occurred Jan 6, 2026
Report 1823260-2026-00319 · MDR key 24221768
Device
Generic name
Test, Carbohydrate Antigen (ca19-9)
Manufacturer
Roche DiagnosticsCatalog number
11776193122
Lot number
857263
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- High Test Results
- Low Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS E 411 ANALYZER (DISK SYSTEM) SERIAL NUMBER IS (B)(6).
Description of Event or Problem
THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS CA 19-9 RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 411 ANALYZER (DISK SYSTEM). THE INITIAL RESULT WAS 74.01 U/ML WITH A DATA FLAG. THE FIRST REPEAT RESULT 18.16 U/ML. THE SECOND REPEAT RESULT 1.86 U/ML. THE THIRD REPEAT RESULT 1.61 U/ML. THE INITIAL AND FIRST REPEAT RESULTS WERE QUESTIONED.
Additional Manufacturer Narrative
THE CUSTOMER RAN ONE LEVEL OF CONTROL ON THE DAY OF THE EVENT AND IT WAS WITHIN RANGE. 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.