ELECSYS CA 19-9
Received Sep 30, 2025 · Event occurred Sep 5, 2025
Report 1823260-2025-03983 · MDR key 23178740
Device
Generic name
Test, Carbohydrate Antigen (ca19-9)
Manufacturer
Roche DiagnosticsCatalog number
11776193122
Lot number
78239101
Product problems
- High Test Results
- Non Reproducible Results
- High Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS E411 RACK SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CA 19-9 RESULTS FROM THE COBAS E411 RACK ANALYZER. THE INITIAL RESULT WAS 306.0 U/ML. THE REPEAT RESULTS WERE 16.41 U/ML AND 11.94 U/ML.
Additional Manufacturer Narrative
DUE TO THE LIMITED INFORMATION PROVIDED, THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. A GENERAL REAGENT OR ANALYZER PROBLEM WAS NOT PRESENT BECAUSE THE QC PRIOR TO THE EVENT WAS WITHIN RANGES. THERE WAS NO PRODUCT PROBLEM IDENTIFIED.