Rheumatoid Factors II 20764574322Recalls & reported problems
Roche Diagnostics GmbH · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04015630914524), received between Aug 14, 2025 and Aug 14, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “High Test Results” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- High Test Results1
- Non Reproducible Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results
THERE WAS AN ALLEGATION OF QUESTIONABLE RHEUMATOID FACTORS II RESULT WITH ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 COBAS C 502 MODULE. ON (B)(6) 2025: THE INITIAL RESULT WAS FLAGGED, WHICH TRIGGERED AUTODILUTION OF THE SAMPLE. THE DILUTION RESULT WAS 261.8 IU/ML. ON (B)(6) 2025: THE REPEAT RESULTS WERE 18.6 IU/ML, 19.7 IU/ML, AND 21.2 IU/ML. THE REPEAT RESULTS WERE DEEMED CORRECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22807082 ↗
Other SYSTEM, TEST, RHEUMATOID FACTOR devices
- Rheumatoid Factor (RF) Kit for use on SPAPLUS LK151.S.AThe Binding Site Group Limited · System, Test, Rheumatoid Factor1 recall0 reports
- EliA RF IgM Well DECC056000Phadia AB · SYSTEM, TEST, RHEUMATOID FACTOR1 recall0 reports
- Rheumatoid Factors II 5480167190Roche Diagnostics GmbH · SYSTEM, TEST, RHEUMATOID FACTOR3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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