Enzyme Linked Immunoabsorbent Assay, Rubella
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 §866.3510 (Microbiology panel).
FDA MAUDE casebook
openFDA event book Enzyme Linked Immunoabsorbent Assay, Rubella LIGHT-BOOK · MAUDE
#753 of 1000 · 761 reports · 2007–2026
- BOOK 761 reports
- RANK #753 of 1000
- DEATH 0 death-typed
- INJ 3 injury-typed
- MALF 753 malfunction
- SPAN 2007–2026
- PEAK 2008: 367
- PHOTO Needle, Fistula
Nearest event-volume peer: Needle, Fistula (0 report gap)
Enzyme Linked Immunoabsorbent Assay, Rubella sits #753 of 1000 among tracked device types with 761 MAUDE reports spanning 2007–2026. 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, Rubella carries 98.9% MALFUNCTION-coded reports, 34.1pp 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 0.4% corpus 30.3% · below corpus mean (-29.9 pp)
- MALF 98.9% corpus 64.8% · above corpus mean (+34.1 pp)
Lead product-problem code Calibration Error is 33% of coded problems · Lead manufacturer ABBOTT LABORATORIES accounts for 58% of manufacturer-tagged reports · Top event location is 78% of location-tagged rows .
Enzyme Linked Immunoabsorbent Assay, Rubella in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Culture Media
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
762 reports
- Table
Table, Radiographic, Tilting
762 reports
- Enzyme Linked… (this)
Enzyme Linked Immunoabsorbent Assay, Rubella
761 reports
- Needle
Needle, Fistula
761 reports
- Mesh
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
756 reports
- Punch
Punch, Surgical
756 reports
What this shows Enzyme Linked Immunoabsorbent Assay, Rubella carries 761 MAUDE reports, ranked #753 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 in 2025 (12) held close to the prior two-year average of 10.
Related Entities for Enzyme Linked Immunoabsorbent Assay, Rubella
Top Manufacturers
Event Locations
Nationwide devices with a comparable report-volume footprint
Enzyme Linked Immunoabsorbent Assay, Rubella 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 (761 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 Immunoabsorbent Assay, Rubella 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, Rubella; 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.