ELECSYS CA 19-9
Received Jun 18, 2026 · Event occurred May 27, 2026
Report 1823260-2026-02428 · MDR key 25543753
Device
Generic name
Carbohydrate Antigen (ca19-9) Test System
Manufacturer
Roche DiagnosticsCatalog number
07027028190
Lot number
89820301
Product problems
- High 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). NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.
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 60.7 U/ML. THE REPEAT RESULT WAS 2.00 U/ML WITH FLAG. THE SAMPLE WAS REPEATED 5 MORE TIMES AND ALL RESULTS WERE <2 U/ML. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.