ELECSYS CA 19-9
Received Jan 12, 2026 · Event occurred Dec 22, 2025
Report 1823260-2026-00142 · MDR key 24038449
Device
Generic name
Test, Carbohydrate Antigen (ca19-9)
Manufacturer
Roche DiagnosticsCatalog number
11776193122
Lot number
857263
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AN ADDITIONAL RESULT WAS PROVIDED FOR THE PATIENT FROM (B)(6) 2025, OF 121.6 U/ML. QC WAS WITHIN RANGE ON THE DATE OF THE EVENT. CALIBRATION SIGNALS WERE SLIGHTLY LOWER BUT ACCEPTABLE. THE SAMPLE WAS REQUESTED BUT IS NOT AVAILABLE FOR INVESTIGATION; THEREFORE, A THOROUGH INVESTIGATION COULD NOT BE COMPLETED. THE INVESTIGATION WAS UNABLE TO DETERMINE A DIRECT ROOT CAUSE.
Additional Manufacturer Narrative
THE COBAS E 411 ANALYZER (DISK SYSTEM) SERIAL NUMBER IS (B)(6) THE SAMPLES HAVE BEEN REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS CA 19-9 RESULT FROM THE COBAS E 411 ANALYZER (DISK SYSTEM) FOR ONE PATIENT. THE INITIAL RESULT WAS 1000 U/ML, ACCOMPANIED BY A DATA FLAG. THE SECOND RESULT WITH A DILUTION OF 1:10 WAS 172 U/ML. THE THIRD RESULT WAS 331.4 U/ML. THE RESULT ON ANOTHER E411 WAS 1000 U/ML, ACCOMPANIED BY A DATA FLAG. A NEW SAMPLE WAS COLLECTED ON THE SAME DAY, AND THE INITIAL RESULT WAS 29.71 U/ML. THE RESULTS FROM THE OTHER E411 WERE 27.22 U/ML AND 32.65 U/ML, WHICH WERE DEEMED TO BE CORRECT. ON (B)(6) 2025, THE SAMPLE WAS SENT TO ANOTHER LAB. THE RESULT ON AN E 411 WAS 219.7 U/ML.