ELECSYS CA 19-9
Received Jun 2, 2026 · Event occurred May 11, 2026
Report 1823260-2026-02166 · MDR key 25362276
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
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF DISCREPANT HIGH RESULTS FOR 2 PATIENT SAMPLES TESTED FOR ELECSYS CA 19-9 (CA 19-9) ON A COBAS 8000 CORE UNIT. PATIENT 1 INITIAL RESULT WAS 75.4 U/ML. THE REPEAT RESULT WAS 17.6 U/ML. PATIENT 2 INITIAL RESULT WAS 60.6 U/ML. THE REPEAT RESULT WAS 23.9 U/ML. THE CUSTOMER REPEATS ALL SAMPLES WITH "ABNORMAL" RESULTS. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.
Additional Manufacturer Narrative
THE COBAS 8000 CORE UNIT SERIAL NUMBER WAS (B)(6). QC WAS ACCEPTABLE. THE SAMPLE ASPIRATION AND FLUIDIC PATHWAYS WERE CHECKED, AND NO ISSUES WERE IDENTIFIED. THE INVESTIGATION IS ONGOING.