ELECSYS CA 19-9 IMMUNOASSAY
Received Jun 30, 2026 · Event occurred Jun 8, 2026
Report 1823260-2026-02605 · MDR key 25664137
Device
Generic name
Test, Carbohydrate Antigen (ca19-9)
Manufacturer
Roche DiagnosticsCatalog number
11776193122
Lot number
ASKU
Product problems
- Incorrect Measurement
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS CA 19-9 IMMUNOASSAY (CA 19-9) ON A COBAS E 411 ANALYZER (RACK SYSTEM). THE INITIAL RESULT WAS < 0.600 U/ML. AS THE PATIENT HAD A CA 19-9 RESULT APPROXIMATELY ONE MONTH PRIOR OF 89.30 U/ML, THIS RESULT WAS QUESTIONED. THE CUSTOMER REPEATED THE SAMPLE, AND THE RESULT WAS < 0.600 U/ML. THE CUSTOMER SENT THE SAMPLE TO ANOTHER LABORATORY USING A ROCHE INSTRUMENT, AND THE RESULT WAS 106.50 U/ML.
Additional Manufacturer Narrative
THE E411 ANALYZER SERIAL NUMBER WAS (B)(6).