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2026 data FDA MAUDE openFDA

Radioimmunoassay, Thyroid-Stimulating Hormone

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.

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FDA MAUDE casebook

openFDA event book Radioimmunoassay LIGHT-BOOK · MAUDE

#418 of 1000 · 2,735 reports · 1994–2026

  • BOOK 2,735 reports
  • RANK #418 of 1000
  • DEATH 0 death-typed
  • INJ 70 injury-typed
  • MALF 2,658 malfunction
  • SPAN 1994–2026
  • PEAK 2018: 249
  • PHOTO Separator

Nearest event-volume peer: Separator, Automated, Blood Cell And Plasma, Therapeutic (4 report gap)

Radioimmunoassay, Thyroid-Stimulating Hormone sits #418 of 1000 among tracked device types with 2,735 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 →

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 2.6% corpus 30.4% · below corpus mean (-27.9 pp)
  • MALF 97.2% corpus 64.5% · above corpus mean (+32.7 pp)

Lead product-problem code Low Test Results is 45% of coded problems · Lead manufacturer ROCHE DIAGNOSTICS accounts for 55% of manufacturer-tagged reports · Top event location is 47% of location-tagged rows .

Radioimmunoassay in the event-volume neighbourhood

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

reports

What this shows Radioimmunoassay, Thyroid-Stimulating Hormone carries 2,735 MAUDE reports, ranked #418 of 1000.

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

Event Types

Malfunction 2,658 (97.2%)
Injury 70 (2.6%)
Other 5 (0.2%)
2 (0.1%)

Patient Outcomes

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

2,643 (96.7%)
Other 64 (2.3%)
Disability 13 (0.5%)
Required Intervention 7 (0.3%)
Hospitalization 6 (0.2%)

Top Product Problems

Low Test Results 858
High Test Results 651
Incorrect Or Inadequate Test Results 100
Non Reproducible Results 91
Incorrect, Inadequate or Imprecise Result or Readings 83
Adverse Event Without Identified Device or Use Problem 29
High Readings 15
No Apparent Adverse Event 14
Device Damaged Prior to Use 11
Unable to Obtain Readings 11
Low Readings 10
Incorrect Measurement 9
Insufficient Information 7
Chemical Problem 5
Appropriate Term/Code Not Available 3
Output Problem 3
Device Operates Differently Than Expected 2
False Positive Result 2
Material Integrity Problem 2
Cross Reactivity 1

Yearly Trend

94
1994: 1
02
2002: 1
03
2003: 1
04
2004: 6
05
2005: 3
06
2006: 11
07
2007: 19
08
2008: 10
09
2009: 41
10
2010: 34
11
2011: 167
12
2012: 144
13
2013: 168
14
2014: 155
15
2015: 203
16
2016: 183
17
2017: 235
18
2018: 249
19
2019: 216
20
2020: 145
21
2021: 146
22
2022: 137
23
2023: 162
24
2024: 169
25
2025: 104
26
2026: 25

Related Entities for Radioimmunoassay, Thyroid-Stimulating Hormone

Top Manufacturers

ROCHE DIAGNOSTICS 1,051
ORTHO-CLINICAL DIAGNOSTICS 534
BECKMAN COULTER, INC. 107
SIEMENS HEALTHCARE DIAGNOSTICS, INC. 93
BECKMAN COULTER 67
BECKMAN COULTER INC. 60

Event Locations

1,281 (46.8%)
I 1,169 (42.7%)
LABORATORY 255 (9.3%)
NO INFORMATION 15 (0.5%)
OTHER 11 (0.4%)
HOSPITAL 2 (0.1%)
INVALID DATA 1 (0.0%)
NOT APPLICABLE 1 (0.0%)

Compare ROCHE DIAGNOSTICS vs ORTHO-CLINICAL DIAGNOSTICS →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Radioimmunoassay, 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 (2,735 here).

Separator 2,731 Vehicle, Motorized 3-Wheeled 2,699 Drills, Burrs, Trephines & Accessories 2,698 Lithotriptor, Biliary Mechanical 2,772

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 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; 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.