PlainHospital
2026 data FDA MAUDE openFDA

Radioimmunoassay, Estradiol

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.

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Radioimmunoassay, Estradiol LIGHT-BOOK · MAUDE

#764 of 1000 · 689 reports · 1994–2026

  • BOOK 689 reports
  • RANK #764 of 1000
  • DEATH 1 death-typed
  • INJ 80 injury-typed
  • MALF 593 malfunction
  • SPAN 1994–2026
  • PEAK 2020: 135
  • PHOTO Endoscopic Cytology B…

Nearest event-volume peer: Endoscopic Cytology Brush (3 report gap)

Radioimmunoassay, Estradiol sits #764 of 1000 among tracked device types with 689 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 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 11.6% corpus 30.4% · below corpus mean (-18.8 pp)
  • MALF 86.1% corpus 64.5% · above corpus mean (+21.6 pp)

Lead product-problem code High Test Results is 41% of coded problems · Lead manufacturer ROCHE DIAGNOSTICS accounts for 65% of manufacturer-tagged reports · Top event location is 52% of location-tagged rows .

Radioimmunoassay, Estradiol in the event-volume neighbourhood

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

reports

What this shows Radioimmunoassay, Estradiol carries 689 MAUDE reports, ranked #764 of 1000.

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

Event Types

Malfunction 593 (86.1%)
Injury 80 (11.6%)
Other 15 (2.2%)
Death 1 (0.1%)

Patient Outcomes

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

605 (87.6%)
Other 72 (10.4%)
Disability 6 (0.9%)
Hospitalization 3 (0.4%)
O 2 (0.3%)
Required Intervention 2 (0.3%)
Death 1 (0.1%)

Top Product Problems

High Test Results 319
Low Test Results 138
Non Reproducible Results 106
Incorrect, Inadequate or Imprecise Result or Readings 88
Incorrect Measurement 32
Adverse Event Without Identified Device or Use Problem 26
Incorrect Or Inadequate Test Results 14
No Apparent Adverse Event 14
Calibration Problem 6
Insufficient Information 4
Low Readings 4
High Readings 3
Output Problem 3
Device Damaged Prior to Use 2
Failure to Calibrate 2
Material Integrity Problem 2
Mechanical Problem 2
Unable to Obtain Readings 2
Appropriate Term/Code Not Available 1
Chemical Problem 1

Yearly Trend

94
1994: 1
97
1997: 1
99
1999: 2
08
2008: 1
09
2009: 9
10
2010: 12
11
2011: 10
12
2012: 15
13
2013: 4
14
2014: 12
15
2015: 18
16
2016: 29
17
2017: 39
18
2018: 38
19
2019: 36
20
2020: 135
21
2021: 43
22
2022: 61
23
2023: 60
24
2024: 65
25
2025: 86
26
2026: 12

Related Entities for Radioimmunoassay, Estradiol

Top Manufacturers

ROCHE DIAGNOSTICS 261
SIEMENS HEALTHCARE DIAGNOSTICS, INC. 87
SIEMENS HEALTHCARE DIAGNOSTICS INC. 47
BECKMAN COULTER 9

Event Locations

358 (52.0%)
I 302 (43.8%)
LABORATORY 22 (3.2%)
OTHER 3 (0.4%)
HOSPITAL 2 (0.3%)
OUTPATIENT TREATMENT FACILITY 2 (0.3%)

Compare ROCHE DIAGNOSTICS vs SIEMENS HEALTHCARE DIAGNOSTICS, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Radioimmunoassay, Estradiol, 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 (689 here).

Endoscopic Cytology Brush 686 Subsystem, Water Purification 686 System 692 Implanted Brain Stimulator For Epilepsy 693

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Abutment, Implant, Dental, Endosseous 1 Active Implantable Bone Conduction Hearing… 1 Aid, Surgical, Viscoelastic 1 Alarm, Conditioned Response Enuresis 1

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

Disclaimer: MAUDE figures for Radioimmunoassay, Estradiol 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, Estradiol; 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.