ELECSYS CA 15-3 II
Received Aug 21, 2025 · Event occurred Jul 25, 2025
Report 1823260-2025-02576 · MDR key 22863385
Device
Generic name
Tumor-associated Antigen Immunological Test System
Manufacturer
Roche DiagnosticsCatalog number
03045838122
Lot number
ASKU
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE ANALYZER WAS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS CA 15-3 II ASSAY RESULT FOR ONE PATIENT SAMPLE TESTED ON A COBAS 6000 E601 MODULE. THE INITIAL RESULT WAS 137.7 KU/L. THE FIRST REPEAT RESULT WAS 183.5 KU/L. THE SECOND REPEAT RESULT WAS 144.9 KU/L. THE SECOND REPEAT RESULT WAS REPORTED OUT.
Additional Manufacturer Narrative
QC WAS ACCEPTABLE. REVIEW OF THE ALARM TRACE DID NOT SHOW ANY ISSUES. A REVIEW OF THE PREANALYTICAL INFORMATION SHOWED THAT THE CUSTOMER IS NOT FOLLOWING THE TUBE MANUFACTURER'S INSTRUCTIONS. THE INVESTIGATION DID NOT IDENTIFY A PROBLEM. THE ISSUE WAS DETERMINED TO BE DUE TO PRE-ANALYTICAL HANDLING ISSUES AT THE CUSTOMER SITE. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY.