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2026 data FDA MAUDE openFDA

Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

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.

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FDA MAUDE casebook

openFDA event book Enzyme Linked Immunoabsorbent Assay LIGHT-BOOK · MAUDE

#545 of 1000 · 1,544 reports · 1998–2026

  • BOOK 1,544 reports
  • RANK #545 of 1000
  • DEATH 0 death-typed
  • INJ 10 injury-typed
  • MALF 1,496 malfunction
  • SPAN 1998–2026
  • PEAK 2017: 173
  • PHOTO Barrier

Nearest event-volume peer: Barrier, Absorbable, Adhesion (6 report gap)

Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii sits #545 of 1000 among tracked device types with 1,544 MAUDE reports spanning 1998–2026. 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 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 0.6% corpus 30.4% · below corpus mean (-29.8 pp)
  • MALF 96.9% corpus 64.5% · above corpus mean (+32.4 pp)

Lead product-problem code False Positive Result is 28% of coded problems · Lead manufacturer SIEMENS HEALTHCARE DIAGNOSTICS INC. accounts for 20% of manufacturer-tagged reports · Top event location is 54% of location-tagged rows .

Enzyme Linked Immunoabsorbent Assay in the event-volume neighbourhood

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

reports

What this shows Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii carries 1,544 MAUDE reports, ranked #545 of 1000.

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

Event Types

Malfunction 1,496 (96.9%)
Other 37 (2.4%)
Injury 10 (0.6%)
1 (0.1%)

Patient Outcomes

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

1,527 (99.1%)
Other 8 (0.5%)
Required Intervention 4 (0.3%)
Disability 1 (0.1%)
Hospitalization 1 (0.1%)

Top Product Problems

False Positive Result 280
High Test Results 243
Adverse Event Without Identified Device or Use Problem 217
Mechanical Problem 85
False Negative Result 44
Incorrect, Inadequate or Imprecise Result or Readings 44
No Apparent Adverse Event 42
Low Test Results 29
Non Reproducible Results 14
Insufficient Information 6
Device Issue 5
Device Operational Issue 2
Incorrect Or Inadequate Test Results 2
Device Displays Incorrect Message 1
Human Factors Issue 1
Power Problem 1

Yearly Trend

98
1998: 1
01
2001: 1
02
2002: 1
04
2004: 5
05
2005: 11
06
2006: 4
07
2007: 4
08
2008: 14
09
2009: 91
10
2010: 71
11
2011: 115
12
2012: 75
13
2013: 35
14
2014: 22
15
2015: 121
16
2016: 140
17
2017: 173
18
2018: 100
19
2019: 59
20
2020: 87
21
2021: 38
22
2022: 73
23
2023: 118
24
2024: 81
25
2025: 91
26
2026: 13

Related Entities for Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

Top Manufacturers

SIEMENS HEALTHCARE DIAGNOSTICS INC. 254
ROCHE DIAGNOSTICS 237
SIEMENS HEALTHCARE DIAGNOSTICS, INC. 222
ABBOTT GMBH 181
BECKMAN COULTER 161
ABBOTT LABORATORIES 108
BECKMAN COULTER INC. 89
ABBOTT MANUFACTURING, INC. 42

Event Locations

840 (54.4%)
I 647 (41.9%)
LABORATORY 37 (2.4%)
OTHER 18 (1.2%)
NO INFORMATION 2 (0.1%)

Compare SIEMENS HEALTHCARE DIAGNOSTICS INC. vs ROCHE DIAGNOSTICS →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Enzyme Linked Immunoabsorbent Assay, 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 (1,544 here).

Barrier, Absorbable, Adhesion 1,538 Over-The-Counter Automated External Defibri… 1,538 Reagent, Coronavirus Serological 1,550 Equipment 1,536

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 Enzyme Linked Immunoabsorbent Assay 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 Enzyme Linked Immunoabsorbent Assay; 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.