2025 data FDA MAUDE openFDA

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 MAUDE casebook

openFDA event book System, Test, Rheumatoid Factor LIGHT-BOOK · MAUDE

#858 of 1000 · 517 reports · 1994–2025

  • BOOK 517 reports
  • RANK #858 of 1000
  • DEATH 0 death-typed
  • INJ 11 injury-typed
  • MALF 504 malfunction
  • SPAN 1994–2025
  • PEAK 2011: 400
  • PHOTO Computer

Nearest event-volume peer: Computer, Blood-Pressure (1 report gap)

System, Test, Rheumatoid Factor sits #858 of 1000 among tracked device types with 517 MAUDE reports spanning 1994–2025. 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 2.1% corpus 30.4% · below corpus mean (-28.3 pp)
  • MALF 97.5% corpus 64.5% · above corpus mean (+33.0 pp)

Lead product-problem code Low Test Results is 22% 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

reports

What this shows System, Test, Rheumatoid Factor carries 517 MAUDE reports, ranked #858 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 504 (97.5%)
Injury 11 (2.1%)
2 (0.4%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

509 (98.5%)
Other 7 (1.4%)
Hospitalization 1 (0.2%)

Top Product Problems

Low Test Results 2
Non Reproducible Results 2
Device Handling Problem 1
High Test Results 1
Incorrect, Inadequate or Imprecise Result or Readings 1
Output Problem 1
Product Quality Problem 1

Yearly Trend

94
1994: 1
10
2010: 19
11
2011: 400
12
2012: 91
18
2018: 1
24
2024: 3
25
2025: 2

Related Entities for System, Test, Rheumatoid Factor

Event Locations

515 (99.6%)
HOSPITAL 1 (0.2%)
I 1 (0.2%)

Compare BECKMAN COULTER, INC. vs BECKMAN COULTER INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for System, Test, Rheumatoid Factor, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (517 here).

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

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.