RHEUMATOID FACTORS II
Received Jun 26, 2026 · Event occurred Jun 9, 2026
Report 1823260-2026-02568 · MDR key 25640508
Device
Generic name
System, Test, Rheumatoid Factor
Manufacturer
Roche DiagnosticsCatalog number
08058628190
Lot number
91742801
Product problems
- High Test Results
Patient
NA · Unknown
- 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 RHEUMATOID FACTORS II ASSAY ON A COBAS C 303 ANALYTICAL UNIT (UNIT 1). THE SAMPLE WAS INITIALLY TESTED ON A DIFFERENT C 303 (UNIT 2), AND THE RESULT WAS 20.3 IU/ML (ACCOMPANIED BY A DATA FLAG). THE SAMPLE WAS THEN REPEATED ON THE C 303 (UNIT 1), AND THE 1ST REPEAT RESULT WAS 13.5 IU/ML (ACCOMPANIED BY A DATA FLAG). THE SAMPLE WAS RETESTED ON THE OTHER C 303 (UNIT 2), AND THE 2ND REPEAT RESULT WAS 6.17 IU/ML (ACCOMPANIED BY A DATA FLAG). THE 2ND REPEAT RESULT WAS DEEMED TO BE CORRECT, BEING "<10 IU/ML", AS IT MATCHED THE PATIENT'S HISTORY AND OTHER TEST RESULTS, AND WAS REPORTED TO THE PATIENT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY.
Additional Manufacturer Narrative
THE COBAS C 303 ANALYTICAL UNIT (UNIT 1) SERIAL NUMBER WAS (B)(6). THE CUSTOMER MENTIONED THAT THEY HAD QC ISSUES. THE INVESTIGATION IS ONGOING.