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2026 data FDA MAUDE openFDA FDA Class II

Radioimmunoassay, Vancomycin

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 §862.3950 (Clinical Toxicology panel).

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FDA MAUDE casebook

openFDA event book Radioimmunoassay, Vancomycin LIGHT-BOOK · MAUDE

#894 of 1000 · 497 reports · 2002–2026

  • BOOK 497 reports
  • RANK #894 of 1000
  • DEATH 1 death-typed
  • INJ 4 injury-typed
  • MALF 480 malfunction
  • SPAN 2002–2026
  • PEAK 2012: 80
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained (0 report gap)

Radioimmunoassay, Vancomycin sits #894 of 1000 among tracked device types with 497 MAUDE reports spanning 2002–2026. 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, Vancomycin carries 96.6% MALFUNCTION-coded reports, 31.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 0.8% corpus 30.3% · below corpus mean (-29.5 pp)
  • MALF 96.6% corpus 64.8% · above corpus mean (+31.8 pp)

Lead product-problem code High Test Results is 37% of coded problems · Lead manufacturer ROCHE DIAGNOSTICS accounts for 36% of manufacturer-tagged reports · Top event location is 70% of location-tagged rows .

Radioimmunoassay, Vancomycin in the event-volume neighbourhood

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

reports

What this shows Radioimmunoassay, Vancomycin carries 497 MAUDE reports, ranked #894 of 1000.

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

Event Types

Malfunction 480 (96.6%)
Other 10 (2.0%)
Injury 4 (0.8%)
2 (0.4%)
Death 1 (0.2%)

Patient Outcomes

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

481 (96.6%)
Other 14 (2.8%)
S 1 (0.2%)
Congenital Anomaly 1 (0.2%)
Required Intervention 1 (0.2%)

Top Product Problems

High Test Results 205
Low Test Results 170
Incorrect Or Inadequate Test Results 89
Incorrect, Inadequate or Imprecise Result or Readings 18
Nonstandard Device 14
False Negative Result 8
Device Handling Problem 6
False Positive Result 6
Non Reproducible Results 6
Adverse Event Without Identified Device or Use Problem 5
Incorrect Measurement 5
Device Ingredient or Reagent Problem 4
Low Readings 4
Other (for use when an appropriate device code cannot be identified) 3
Cross Reactivity 2
Device Operates Differently Than Expected 2
False Reading From Device Non-Compliance 2
High Readings 2
Improper or Incorrect Procedure or Method 2
Leak/Splash 2

Yearly Trend

02
2002: 1
07
2007: 4
08
2008: 12
09
2009: 25
10
2010: 48
11
2011: 55
12
2012: 80
13
2013: 73
14
2014: 40
15
2015: 26
16
2016: 10
17
2017: 15
18
2018: 17
19
2019: 13
20
2020: 14
21
2021: 11
22
2022: 7
23
2023: 11
24
2024: 14
25
2025: 14
26
2026: 7

Reports in 2025 (14) held close to the prior two-year average of 13.

Related Entities for Radioimmunoassay, Vancomycin

Top Manufacturers

ROCHE DIAGNOSTICS 107
ORTHO-CLINICAL DIAGNOSTICS 103
SIEMENS HEALTHCARE DIAGNOSTICS, INC. 35
SIEMENS HEALTHCARE DIAGNOSTICS INC. 27
SIEMENS HEALTHCARE DIAGNOSTICS INC 12
ABBOTT GMBH 7
BECKMAN COULTER, INC. 7

Event Locations

346 (69.6%)
I 79 (15.9%)
LABORATORY 63 (12.7%)
OTHER 8 (1.6%)
HOSPITAL 1 (0.2%)

Compare ROCHE DIAGNOSTICS vs ORTHO-CLINICAL DIAGNOSTICS →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Radioimmunoassay, Vancomycin: 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 (497 here).

Prosthesis 497 Normothermic Machine Perfusion System For T… 498 Glue, Surgical, Arteries 495 Prosthesis 499

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, Vancomycin 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, Vancomycin; 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.