ELECSYS CA 19-9
Received Apr 3, 2026 · Event occurred Mar 9, 2026
Report 1823260-2026-01259 · MDR key 24777722
Device
Generic name
Test, Carbohydrate Antigen (ca19-9)
Manufacturer
Roche DiagnosticsCatalog number
07027028188
Lot number
86153800
Product problems
- High Test Results
- Low Test Results
- Non Reproducible Results
Patient
37 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CA 19-9 RESULTS FOR 4 PATIENT SAMPLES ON A COBAS E 801 ANALYTICAL UNIT. PATIENT 1: THE INITIAL RESULT WAS 40 U/ML. ON (B)(6) 2026, A NEW SAMPLE FROM THE PATIENT WAS TESTED, AND THE RESULT WAS 13.9 U/ML. THE INITIAL SAMPLE WAS RETESTED, AND THE RESULT WAS 14.3 U/ML. PATIENT 2: ON (B)(6) 2026, THE INITIAL RESULT WAS 67 U/ML, AND THE REPEATED RESULT WAS 26.7 U/ML. PATIENT 3: ON (B)(6) 2026, THE INITIAL RESULT WAS 61.7 U/ML, AND THE REPEATED RESULT WAS 27 U/ML. PATIENT 4: ON (B)(6) 2026, THE INITIAL RESULT WAS 40.8 U/ML, AND THE REPEATED RESULT WAS 28.1 U/ML.
Additional Manufacturer Narrative
THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.