PlainHospital
2026 data FDA MAUDE openFDA FDA Class II

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.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §862.1690 (Clinical Chemistry panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Radioimmunoassay LIGHT-BOOK · MAUDE

#426 of 1000 · 2,771 reports · 1994–2026

  • BOOK 2,771 reports
  • RANK #426 of 1000
  • DEATH 0 death-typed
  • INJ 71 injury-typed
  • MALF 2,688 malfunction
  • SPAN 1994–2026
  • PEAK 2018: 249
  • PHOTO Separator

Nearest event-volume peer: Separator, Automated, Blood Cell And Plasma, Therapeutic (2 report gap)

Radioimmunoassay, Thyroid-Stimulating Hormone sits #426 of 1000 among tracked device types with 2,771 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

Radioimmunoassay carries 97.0% MALFUNCTION-coded reports, 32.2pp 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 2.6% corpus 30.3% · below corpus mean (-27.7 pp)
  • MALF 97.0% corpus 64.8% · above corpus mean (+32.2 pp)

Lead product-problem code Low Test Results is 40% of coded problems · Lead manufacturer ROCHE DIAGNOSTICS accounts for 55% of manufacturer-tagged reports · Top event location is 48% 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 2,771 MAUDE reports, ranked #426 of 1000.

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

Event Types

Malfunction 2,688 (97.0%)
Injury 71 (2.6%)
Other 10 (0.4%)
2 (0.1%)

Patient Outcomes

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

2,677 (96.7%)
Other 64 (2.3%)
Disability 14 (0.5%)
Required Intervention 7 (0.3%)
Hospitalization 6 (0.2%)
O 1 (0.0%)

Top Product Problems

Low Test Results 1,177
High Test Results 986
Incorrect Or Inadequate Test Results 365
Incorrect, Inadequate or Imprecise Result or Readings 130
Non Reproducible Results 94
Adverse Event Without Identified Device or Use Problem 31
False Positive Result 24
High Readings 17
Nonstandard Device 16
No Apparent Adverse Event 15
False Negative Result 14
Device Damaged Prior to Use 11
Low Readings 11
Unable to Obtain Readings 11
Detachment Of Device Component 9
Incorrect Measurement 9
Insufficient Device Problem Information 8
False Reading From Device Non-Compliance 7
Chemical Problem 6
Component Falling 6

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: 61

Reports fell to 104 in 2025, down from an average of 166 in the two years before.

Related Entities for Radioimmunoassay, Thyroid-Stimulating Hormone

Top Manufacturers

ROCHE DIAGNOSTICS 1,058
ORTHO-CLINICAL DIAGNOSTICS 534
BECKMAN COULTER, INC. 107
SIEMENS HEALTHCARE DIAGNOSTICS, INC. 93
BECKMAN COULTER 67
BECKMAN COULTER INC. 60

Event Locations

1,317 (47.5%)
I 1,169 (42.2%)
LABORATORY 255 (9.2%)
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 a comparable report-volume footprint

Radioimmunoassay 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 (2,771 here).

Separator 2,769 Catheter And Tip, Suction 2,781 Prosthesis, Penile 2,754 Real Time Nucleic Acid Amplification System 2,746

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.