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2026 data FDA MAUDE openFDA FDA Class II

Radioimmunoassay, Total Triiodothyronine

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 §862.1710 (Clinical Chemistry panel).

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FDA MAUDE casebook

openFDA event book Radioimmunoassay, Total Triiodothyronine LIGHT-BOOK · MAUDE

#506 of 1000 · 1,979 reports · 1997–2026

  • BOOK 1,979 reports
  • RANK #506 of 1000
  • DEATH 0 death-typed
  • INJ 14 injury-typed
  • MALF 1,955 malfunction
  • SPAN 1997–2026
  • PEAK 2018: 365
  • PHOTO Monitor

Nearest event-volume peer: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) (4 report gap)

Radioimmunoassay, Total Triiodothyronine sits #506 of 1000 among tracked device types with 1,979 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, Total Triiodothyronine carries 98.8% MALFUNCTION-coded reports, 34.0pp 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 0.7% corpus 30.3% · below corpus mean (-29.6 pp)
  • MALF 98.8% corpus 64.8% · above corpus mean (+34.0 pp)

Lead product-problem code High Test Results is 46% of coded problems · Lead manufacturer ROCHE DIAGNOSTICS accounts for 95% of manufacturer-tagged reports · Top event location I is 67% of location-tagged rows .

Radioimmunoassay, Total Triiodothyronine in the event-volume neighbourhood

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

reports

What this shows Radioimmunoassay, Total Triiodothyronine carries 1,979 MAUDE reports, ranked #506 of 1000.

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

Event Types

Malfunction 1,955 (98.8%)
Injury 14 (0.7%)
Other 10 (0.5%)

Patient Outcomes

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

1,963 (99.2%)
Other 10 (0.5%)
Disability 2 (0.1%)
Hospitalization 2 (0.1%)
O 1 (0.1%)

Top Product Problems

High Test Results 1,018
Low Test Results 307
Low Readings 298
Incorrect Or Inadequate Test Results 263
Non Reproducible Results 95
Incorrect, Inadequate or Imprecise Result or Readings 93
Nonstandard Device 62
Incorrect Measurement 14
Adverse Event Without Identified Device or Use Problem 13
Device Ingredient or Reagent Problem 9
High Readings 6
Insufficient Device Problem Information 6
Output Problem 6
Chemical Problem 5
Component Missing 3
Device Operates Differently Than Expected 2
False Positive Result 2
Leak/Splash 2
Appropriate Device Problem Term/Code Not Available 1
Crack 1

Yearly Trend

97
1997: 1
04
2004: 2
10
2010: 3
11
2011: 8
12
2012: 2
13
2013: 10
14
2014: 111
15
2015: 158
16
2016: 150
17
2017: 151
18
2018: 365
19
2019: 343
20
2020: 209
21
2021: 120
22
2022: 123
23
2023: 131
24
2024: 41
25
2025: 25
26
2026: 26

Reports fell to 25 in 2025, down from an average of 86 in the two years before.

Related Entities for Radioimmunoassay, Total Triiodothyronine

Top Manufacturers

ROCHE DIAGNOSTICS 1,265
BECKMAN COULTER 34
Roche Diagnostics 10
SIEMENS HEALTHCARE DIAGNOSTICS, INC. 10
ORTHO-CLINICAL DIAGNOSTICS 6

Event Locations

I 1,321 (66.8%)
488 (24.7%)
LABORATORY 166 (8.4%)
HOSPITAL 1 (0.1%)
NO INFORMATION 1 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)
UNKNOWN 1 (0.1%)

Compare ROCHE DIAGNOSTICS vs BECKMAN COULTER →

Nationwide devices with a comparable report-volume footprint

Radioimmunoassay, Total Triiodothyronine 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 (1,979 here).

Monitor, Physiological, Patient 1,983 Tourniquet, Pneumatic 1,989 Tubes, Vacuum Sample, With Anticoagulant 1,965 Trocar 1,994

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, Total Triiodothyronine 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, Total Triiodothyronine; 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.