ELECSYS ANTI-CCP
Received Dec 3, 2025 · Event occurred Nov 13, 2025
Report 1823260-2025-04936 · MDR key 23707771
Device
Generic name
Antibodies, Anti-cyclic Citrullinated Peptide (ccp)
Manufacturer
Roche DiagnosticsCatalog number
05031656190
Lot number
ASKU
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Non Reproducible Results
- Incorrect, Inadequate or Imprecise Result or Readings
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION DETERMINED THE ISSUE IS CONSISTENT WITH HEMOLYSIS OF THE PATIENT SAMPLE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT ISSUE.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE E411 ANALYZER WAS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS ANTI-CCP ON A COBAS E411 RACK. THE SAMPLE INITIALLY RESULTED IN AN ANTI-CCP VALUE OF 50 U/ML. THE SAMPLE WAS DILUTED X 5 USING LOW CONCENTRATION PATIENT SERUM AND REPEATED, RESULTING IN AN ANTI-CCP VALUE OF 660 U/ML.