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2026 data FDA MAUDE openFDA FDA Class II

Radioimmunoassay, Free Thyroxine

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 §862.1695 (Clinical Chemistry panel).

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FDA MAUDE casebook

openFDA event book Radioimmunoassay, Free Thyroxine LIGHT-BOOK · MAUDE

#509 of 1000 · 1,922 reports · 1997–2026

  • BOOK 1,922 reports
  • RANK #509 of 1000
  • DEATH 0 death-typed
  • INJ 25 injury-typed
  • MALF 1,891 malfunction
  • SPAN 1997–2026
  • PEAK 2024: 276
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Mitral Valve, Percutaneously Delivered (8 report gap)

Radioimmunoassay, Free Thyroxine sits #509 of 1000 among tracked device types with 1,922 MAUDE reports spanning 1997–2026. 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

Radioimmunoassay, Free Thyroxine carries 98.4% MALFUNCTION-coded reports, 33.6pp 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 1.3% corpus 30.3% · below corpus mean (-29.0 pp)
  • MALF 98.4% corpus 64.8% · above corpus mean (+33.6 pp)

Lead product-problem code High Test Results is 67% of coded problems · Lead manufacturer ROCHE DIAGNOSTICS accounts for 95% of manufacturer-tagged reports · Top event location I is 47% of location-tagged rows .

Radioimmunoassay, Free Thyroxine in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Radioimmunoassay, Free Thyroxine carries 1,922 MAUDE reports, ranked #509 of 1000.

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

Event Types

Malfunction 1,891 (98.4%)
Injury 25 (1.3%)
Other 4 (0.2%)
2 (0.1%)

Patient Outcomes

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

1,889 (98.5%)
Other 23 (1.2%)
Required Intervention 4 (0.2%)
Disability 1 (0.1%)
Hospitalization 1 (0.1%)

Top Product Problems

High Test Results 1,339
Incorrect Or Inadequate Test Results 202
Low Test Results 188
Non Reproducible Results 100
Incorrect, Inadequate or Imprecise Result or Readings 91
Adverse Event Without Identified Device or Use Problem 27
Incorrect Measurement 18
Calibration Problem 7
False Positive Result 7
High Readings 4
Output Problem 3
Appropriate Device Problem Term/Code Not Available 2
Imprecise or Erratic Results 2
Insufficient Device Problem Information 2
Chemical Problem 1
False Negative Result 1
Human-Device Interface Problem 1
Malfunction 1
Manufacturing, Packaging or Shipping Problem 1
Optical Problem 1

Yearly Trend

97
1997: 1
04
2004: 1
09
2009: 2
10
2010: 7
11
2011: 15
12
2012: 6
13
2013: 6
14
2014: 40
15
2015: 166
16
2016: 148
17
2017: 196
18
2018: 199
19
2019: 167
20
2020: 106
21
2021: 96
22
2022: 81
23
2023: 99
24
2024: 276
25
2025: 213
26
2026: 97

Reports in 2025 (213) held close to the prior two-year average of 188.

Related Entities for Radioimmunoassay, Free Thyroxine

Top Manufacturers

ROCHE DIAGNOSTICS 1,281
SIEMENS HEALTHCARE DIAGNOSTICS, INC. 29
ORTHO-CLINICAL DIAGNOSTICS 19
BECKMAN COULTER 18
BECKMAN COULTER, INC. 4

Event Locations

I 901 (46.9%)
811 (42.2%)
LABORATORY 206 (10.7%)
HOSPITAL 2 (0.1%)
NO INFORMATION 1 (0.1%)
OTHER 1 (0.1%)

Compare ROCHE DIAGNOSTICS vs SIEMENS HEALTHCARE DIAGNOSTICS, INC. →

Nationwide devices with a comparable report-volume footprint

Radioimmunoassay, Free Thyroxine 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 (1,922 here).

Prosthesis 1,930 Calculator, Drug Dose 1,898 Ventilator, Emergency, Manual 1,891 Tubes, Vacuum Sample, With Anticoagulant 1,965

Similar death-typed counts

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

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Radioimmunoassay, Free Thyroxine 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 Radioimmunoassay, Free Thyroxine; 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.