ELECSYS CA 19-9
Received Apr 23, 2026 · Event occurred Mar 31, 2026
Report 1823260-2026-01553 · MDR key 24964544
Device
Generic name
Test, Carbohydrate Antigen (ca19-9)
Manufacturer
Roche DiagnosticsCatalog number
11776193122
Lot number
85726300
Product problems
- False Positive Result
- High Test Results
Patient
61 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS E 602 MODULE SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS CA 19-9 ASSAY ON A COBAS E 602 MODULE. INITIAL RESULT: 97.08 U/ML. THE CUSTOMER PERFORMED POLYETHYLENE GLYCOL (PEG) TREATMENT AND REPEATED THE SAMPLE: 1ST REPEAT RESULT: 10.32 U/ML. 2ND REPEAT RESULT: 11.86 U/ML (TESTED ON THE YAHUILONG INSTRUMENT). THE SAMPLE WAS THEN REPEATED ON AN ABBOTT ALINITY INSTRUMENT: 3RD REPEAT RESULT: >1200 U/ML. 4TH REPEAT RESULT: 5 U/ML (AFTER PEG TREATMENT WAS PERFORMED). NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY AS THEY DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS. THE RESULT OBTAINED ON THE YAHUILONG INSTRUMENT WAS REPORTED TO THE CLINIC.