System, Test, Rheumatoid Factor
Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.
OpenFDA device adverse-event casebook.
FDA Class II (moderate risk, special controls required), regulated under 21 CFR §866.5775 (Immunology panel).
FDA MAUDE casebook
openFDA event book System, Test, Rheumatoid Factor LIGHT-BOOK · MAUDE
#878 of 1000 · 518 reports · 1994–2026
- BOOK 518 reports
- RANK #878 of 1000
- DEATH 0 death-typed
- INJ 11 injury-typed
- MALF 505 malfunction
- SPAN 1994–2026
- PEAK 2011: 400
- PHOTO Total
Nearest event-volume peer: Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer (0 report gap)
System, Test, Rheumatoid Factor sits #878 of 1000 among tracked device types with 518 MAUDE reports spanning 1994–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →
Malfunction reports run above the device-type norm
System, Test, Rheumatoid Factor carries 97.5% MALFUNCTION-coded reports, 32.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
- INJ 2.1% corpus 30.3% · below corpus mean (-28.2 pp)
- MALF 97.5% corpus 64.8% · above corpus mean (+32.7 pp)
Lead product-problem code False Positive Result is 59% of coded problems · Lead manufacturer BECKMAN COULTER, INC. accounts for 59% of manufacturer-tagged reports · Top event location is 100% of location-tagged rows .
System, Test, Rheumatoid Factor in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Display
Display, Cathode-Ray Tube, Medical
525 reports
- Bur, Dental
Bur, Dental
523 reports
- Unit
Unit, X-Ray, Extraoral With Timer
521 reports
- Apparatus
Apparatus, Traction, Non-Powered
519 reports
- System (this)
System, Test, Rheumatoid Factor
518 reports
- Total
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
518 reports
What this shows System, Test, Rheumatoid Factor carries 518 MAUDE reports, ranked #878 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports in 2025 (2) held close to the prior two-year average of 2.
Related Entities for System, Test, Rheumatoid Factor
Top Manufacturers
Event Locations
Nationwide devices with a comparable report-volume footprint
System, Test, Rheumatoid Factor carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (518 here).
Similar death-typed counts
Nearest other device types by death-typed report count (0 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for System, Test, Rheumatoid Factor are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.
Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for System, Test, Rheumatoid Factor; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.