Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
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 §866.3830 (Microbiology panel).
FDA MAUDE casebook
openFDA event book Enzyme Linked Immunoabsorption Assay LIGHT-BOOK · MAUDE
#899 of 1000 · 492 reports · 2000–2026
- BOOK 492 reports
- RANK #899 of 1000
- DEATH 0 death-typed
- INJ 9 injury-typed
- MALF 480 malfunction
- SPAN 2000–2026
- PEAK 2025: 112
- PHOTO Blood Pressure Cuff
Nearest event-volume peer: Blood Pressure Cuff (0 report gap)
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum sits #899 of 1000 among tracked device types with 492 MAUDE reports spanning 2000–2026. 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 Immunoabsorption Assay carries 97.6% MALFUNCTION-coded reports, 32.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
- INJ 1.8% corpus 30.3% · below corpus mean (-28.5 pp)
- MALF 97.6% corpus 64.8% · above corpus mean (+32.7 pp)
Lead product-problem code False Negative Result is 79% of coded problems · Lead manufacturer ABBOTT GMBH accounts for 80% of manufacturer-tagged reports · Top event location is 77% of location-tagged rows .
Enzyme Linked Immunoabsorption Assay in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Angiography/A…
Angiography/Angioplasty Kit
494 reports
- Joint
Joint, Knee, External Limb Component
494 reports
- Enzyme Linked… (this)
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
492 reports
- Blood Pressur…
Blood Pressure Cuff
492 reports
- Prosthesis
Prosthesis, Finger, Constrained, Polymer
492 reports
- Reservoir
Reservoir, Blood, Cardiopulmonary Bypass
490 reports
What this shows Enzyme Linked Immunoabsorption Assay, Treponema Pallidum carries 492 MAUDE reports, ranked #899 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports rose to 112 in 2025, up from an average of 70 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Top Manufacturers
Event Locations
Nationwide devices with a comparable report-volume footprint
Enzyme Linked Immunoabsorption 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 (492 here).
Similar death-typed counts
Nearest other device types by death-typed report count (0 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Enzyme Linked Immunoabsorption 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 Immunoabsorption 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.