PlainHospital
2026 data FDA MAUDE openFDA FDA Class II

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.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §866.3780 (Microbiology panel).

Browse devices → Device safety hub

FDA MAUDE casebook

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

#552 of 1000 · 1,578 reports · 1998–2026

  • BOOK 1,578 reports
  • RANK #552 of 1000
  • DEATH 0 death-typed
  • INJ 4 injury-typed
  • MALF 1,536 malfunction
  • SPAN 1998–2026
  • PEAK 2017: 173
  • PHOTO Tube

Nearest event-volume peer: Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) (5 report gap)

Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii sits #552 of 1000 among tracked device types with 1,578 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 →

Malfunction reports run above the device-type norm

Enzyme Linked Immunoabsorbent Assay carries 97.3% 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 0.3% corpus 30.3% · below corpus mean (-30.0 pp)
  • MALF 97.3% corpus 64.8% · above corpus mean (+32.5 pp)

Lead product-problem code False Positive Result is 35% of coded problems · Lead manufacturer SIEMENS HEALTHCARE DIAGNOSTICS INC. accounts for 19% of manufacturer-tagged reports · Top event location is 55% 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 1,578 MAUDE reports, ranked #552 of 1000.

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

Event Types

Malfunction 1,536 (97.3%)
Other 37 (2.3%)
Injury 4 (0.3%)
1 (0.1%)

Patient Outcomes

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

1,558 (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 575
High Test Results 324
Adverse Event Without Identified Device or Use Problem 221
Incorrect Or Inadequate Test Results 145
False Negative Result 91
Mechanical Problem 85
Incorrect, Inadequate or Imprecise Result or Readings 63
Low Test Results 44
No Apparent Adverse Event 42
Non Reproducible Results 18
Insufficient Device Problem Information 8
Device Issue 5
Device Displays Incorrect Message 2
Device Operational Issue 2
Device Stops Intermittently 2
Incorrect Measurement 2
Component Falling 1
Contamination 1
Device Ingredient or Reagent Problem 1
Human Factors Issue 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: 47

Reports in 2025 (91) held close to the prior two-year average of 100.

Related Entities for Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

Top Manufacturers

SIEMENS HEALTHCARE DIAGNOSTICS INC. 254
ROCHE DIAGNOSTICS 252
SIEMENS HEALTHCARE DIAGNOSTICS, INC. 222
ABBOTT GMBH 198
BECKMAN COULTER 161
ABBOTT LABORATORIES 108
BECKMAN COULTER INC. 89
ABBOTT MANUFACTURING, INC. 42

Event Locations

874 (55.4%)
I 647 (41.0%)
LABORATORY 37 (2.3%)
OTHER 18 (1.1%)
NO INFORMATION 2 (0.1%)

Compare SIEMENS HEALTHCARE DIAGNOSTICS INC. vs ROCHE DIAGNOSTICS →

Nationwide devices with a comparable report-volume footprint

Enzyme Linked Immunoabsorbent Assay 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 (1,578 here).

Tube 1,573 Wrench 1,571 Electrode, Electrocardiograph 1,587 Mattress, Flotation Therapy, Non-Powered 1,569

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.