ELECSYS CA 19-9
Received Oct 24, 2025 · Event occurred Sep 29, 2025
Report 1823260-2025-04343 · MDR key 23381362
Device
Generic name
Test, Carbohydrate Antigen (ca19-9)
Manufacturer
Roche DiagnosticsCatalog number
07027028214
Lot number
84575601
Product problems
- High Test Results
- Non Reproducible Results
- High Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BASED ON THE CALIBRATION AND 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.
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6). CALIBRATION WAS LAST PERFORMED ON (B)(6) 2025. THE QC RECOVERY DATA PROVIDED WAS ACCEPTABLE. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CA 19-9 RESULTS FOR 2 PATIENT SAMPLES ON A COBAS E 801 ANALYTICAL UNIT. ON (B)(6) 2025, SAMPLE 1 HAD AN INITIAL RESULT OF 58 U/ML. THE SAMPLE WAS REPEATED ON ANOTHER E801 ANALYZER AND THE RESULT WAS 3 U/ML. THE SAMPLE WAS REPEATED TWO MORE TIMES ON BOTH ANALYZERS AND THE REPEAT RESULTS WERE BOTH 3 U/ML. ON (B)(6) 2025, SAMPLE 2 HAD AN INITIAL RESULT OF 49 U/ML. THE SAMPLE WAS REPEATED ON ANOTHER E801 ANALYZER AND THE RESULT WAS 27 U/ML. THE SAMPLE WAS RECENTRIFUGED AND REPEATED TWO MORE TIMES ON BOTH ANALYZERS. THE REPEAT RESULT ON THE FIRST ANALYZER WAS 29 U/ML AND THE REPEAT ON THE OTHER ANALYZER WAS 28 U/ML.