ELECSYS CA 19-9
Received Jan 16, 2026 · Event occurred Dec 24, 2025
Report 1823260-2026-00194 · MDR key 24094698
Device
Generic name
Carbohydrate Antigen (ca19-9) Test System
Manufacturer
Roche DiagnosticsCatalog number
07027028190
Lot number
84908301
Product problems
- High Test Results
- Low Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6). THE QC RECOVERY DATA PROVIDED WAS WITHIN SPECIFICATION. THE ALARM TRACE SHOWED SEVEN SAMPLE CLOT DETECTION ALARMS. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CA 19-9 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 46.1 U/ML. THE SAMPLE WAS REPEATED TWICE, AND THE RESULTS WERE BOTH 2.00 U/ML WITH A DATA FLAG. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE DEEMED CORRECT.
Additional Manufacturer Narrative
BASED ON THE QC DATA, A GENERAL REAGENT ISSUE COULD BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.