2026 data FDA MAUDE openFDA FDA Class I

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.

FDA Class I (lowest regulatory risk tier, general controls), regulated under 21 CFR §862.1260 (Clinical Chemistry panel).

FDA MAUDE casebook

openFDA event book Radioimmunoassay, Estradiol LIGHT-BOOK · MAUDE

#771 of 1000 · 719 reports · 1994–2026

  • BOOK 719 reports
  • RANK #771 of 1000
  • DEATH 1 death-typed
  • INJ 81 injury-typed
  • MALF 622 malfunction
  • SPAN 1994–2026
  • PEAK 2020: 135
  • PHOTO Apparatus

Nearest event-volume peer: Apparatus, Exhaust, Surgical (1 report gap)

Radioimmunoassay, Estradiol sits #771 of 1000 among tracked device types with 719 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, Estradiol carries 86.5% MALFUNCTION-coded reports, 21.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 11.3% corpus 30.3% · below corpus mean (-19.0 pp)
  • MALF 86.5% corpus 64.8% · above corpus mean (+21.7 pp)

Lead product-problem code High Test Results is 40% of coded problems · Lead manufacturer ROCHE DIAGNOSTICS accounts for 65% of manufacturer-tagged reports · Top event location is 54% 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 719 MAUDE reports, ranked #771 of 1000.

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

Event Types

Malfunction 622 (86.5%)
Injury 81 (11.3%)
Other 15 (2.1%)
Death 1 (0.1%)

Patient Outcomes

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

629 (88.0%)
Other 72 (10.1%)
Disability 6 (0.8%)
Hospitalization 3 (0.4%)
O 2 (0.3%)
Required Intervention 2 (0.3%)
Death 1 (0.1%)

Top Product Problems

High Test Results 360
Low Test Results 177
Non Reproducible Results 118
Incorrect, Inadequate or Imprecise Result or Readings 96
Incorrect Or Inadequate Test Results 39
Incorrect Measurement 37
Adverse Event Without Identified Device or Use Problem 27
No Apparent Adverse Event 14
Calibration Problem 7
Insufficient Device Problem Information 4
Low Readings 4
Output Problem 4
Appropriate Device Problem Term/Code Not Available 3
False Reading From Device Non-Compliance 3
High Readings 3
Chemical Problem 2
Device Damaged Prior to Use 2
Failure to Calibrate 2
Material Integrity Problem 2
Mechanical Problem 2

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: 42

Reports in 2025 (86) held close to the prior two-year average of 63.

Related Entities for Radioimmunoassay, Estradiol

Event Locations

388 (54.0%)
I 302 (42.0%)
LABORATORY 22 (3.1%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Radioimmunoassay, Estradiol: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (719 here).

Similar death-typed counts

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

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.