ELECSYS CA 19-9
Received Jul 8, 2026 · Event occurred Jun 16, 2026
Report 1823260-2026-02742 · MDR key 25746240
Device
Generic name
Test, Carbohydrate Antigen (ca19-9)
Manufacturer
Roche DiagnosticsCatalog number
07027028188
Lot number
939827
Product problems
- No Apparent Adverse Event
- Prophylactic removal due to corrective action
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS CA 19-9 ASSAY ON A COBAS E 801 ANALYTICAL UNIT.INITIAL RESULT: 62.9 U/ML.1ST REPEAT RESULT: 57.4 U/ML.2ND REPEAT RESULT: 65.2 U/ML (TESTED AFTER 25% POLYETHYLENE GLYCOL (PEG) TREATMENT).3RD REPEAT RESULT: 37.8 U/ML (TESTED ON ABBOTT ALINITY).4TH REPEAT RESULT: 35 U/ML (TESTED ON SIEMENS ATELLICA).THE CUSTOMER ALLEGED THAT ROCHE RESULTS WERE HIGHER THAN THE REFERENCE VALUES FOR THE NORMAL POPULATION.NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY AS THEY DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS.THE CUSTOMER REPORTED THE RESULT OBTAINED FROM ABBOTT ALINITY OUTSIDE THE LABORATORY.
Additional Manufacturer Narrative
THE COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER WAS 4(b)(4).THE QC WAS ACCEPTABLE.THE SAMPLE WAS RECEIVED FOR INVESTIGATION ON (b)(6) 2026.THE INVESTIGATION IS ONGOING.