2026 data FDA MAUDE openFDA FDA Class II

Radioimmunoassay, Parathyroid 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 §862.1545 (Clinical Chemistry panel).

FDA MAUDE casebook

openFDA event book Radioimmunoassay, Parathyroid Hormone LIGHT-BOOK · MAUDE

#575 of 1000 · 1,479 reports · 1994–2026

  • BOOK 1,479 reports
  • RANK #575 of 1000
  • DEATH 0 death-typed
  • INJ 20 injury-typed
  • MALF 1,440 malfunction
  • SPAN 1994–2026
  • PEAK 2022: 188
  • PHOTO Indicator

Nearest event-volume peer: Indicator, Biological Sterilization Process (10 report gap)

Radioimmunoassay, Parathyroid Hormone sits #575 of 1000 among tracked device types with 1,479 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, Parathyroid Hormone carries 97.4% MALFUNCTION-coded reports, 32.5pp 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 1.4% corpus 30.3% · below corpus mean (-28.9 pp)
  • MALF 97.4% corpus 64.8% · above corpus mean (+32.5 pp)

Lead product-problem code High Test Results is 46% of coded problems · Lead manufacturer ORTHO-CLINICAL DIAGNOSTICS accounts for 42% of manufacturer-tagged reports · Top event location is 68% of location-tagged rows .

Radioimmunoassay, Parathyroid Hormone in the event-volume neighbourhood

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

reports

What this shows Radioimmunoassay, Parathyroid Hormone carries 1,479 MAUDE reports, ranked #575 of 1000.

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

Event Types

Malfunction 1,440 (97.4%)
Injury 20 (1.4%)
Other 16 (1.1%)
3 (0.2%)

Patient Outcomes

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

1,446 (98.0%)
Other 23 (1.6%)
Hospitalization 4 (0.3%)
Required Intervention 2 (0.1%)
Disability 1 (0.1%)

Top Product Problems

High Test Results 765
Low Test Results 389
False Positive Result 101
Incorrect Or Inadequate Test Results 101
Adverse Event Without Identified Device or Use Problem 73
Nonstandard Device 54
Non Reproducible Results 42
Device Ingredient or Reagent Problem 26
Incorrect, Inadequate or Imprecise Result or Readings 26
High Readings 25
No Apparent Adverse Event 20
Incorrect Measurement 17
Low Readings 7
Calibration Problem 5
Device Operates Differently Than Expected 5
Imprecise or Erratic Results 5
Output Problem 4
Appropriate Device Problem Term/Code Not Available 3
False Reading From Device Non-Compliance 3
Mechanical Problem 3

Yearly Trend

94
1994: 1
06
2006: 4
08
2008: 8
09
2009: 4
10
2010: 23
11
2011: 97
12
2012: 124
13
2013: 172
14
2014: 167
15
2015: 57
16
2016: 98
17
2017: 83
18
2018: 65
19
2019: 77
20
2020: 50
21
2021: 57
22
2022: 188
23
2023: 82
24
2024: 67
25
2025: 38
26
2026: 17

Reports fell to 38 in 2025, down from an average of 75 in the two years before.

Related Entities for Radioimmunoassay, Parathyroid Hormone

Event Locations

1,007 (68.1%)
I 449 (30.4%)
LABORATORY 20 (1.4%)
NO INFORMATION 2 (0.1%)
HOSPITAL 1 (0.1%)

Compare ORTHO-CLINICAL DIAGNOSTICS vs ROCHE DIAGNOSTICS →

Nationwide devices with a comparable report-volume footprint

Radioimmunoassay, Parathyroid Hormone 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 (1,479 here).

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Disclaimer: MAUDE figures for Radioimmunoassay, Parathyroid Hormone 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, Parathyroid Hormone; 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.