Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations
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 MAUDE casebook
openFDA event book Serology Tests Used For Infectious Disease… LIGHT-BOOK · MAUDE
#872 of 1000 · 527 reports · 2019–2026
- BOOK 527 reports
- RANK #872 of 1000
- DEATH 0 death-typed
- INJ 125 injury-typed
- MALF 402 malfunction
- SPAN 2019–2026
- PEAK 2023: 155
- PHOTO Drug-Coated Periphera…
Nearest event-volume peer: Drug-Coated Peripheral Transluminal Angioplasty Catheter (1 report gap)
Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations sits #872 of 1000 among tracked device types with 527 MAUDE reports spanning 2019–2026. 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
Serology Tests Used For Infectious Disease… carries 76.3% MALFUNCTION-coded reports, 11.5pp 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 23.7% corpus 30.3% · below corpus mean (-6.6 pp)
- MALF 76.3% corpus 64.8% · above corpus mean (+11.5 pp)
Lead product-problem code False Positive Result is 88% of coded problems · Lead manufacturer ABBOTT GMBH accounts for 87% of manufacturer-tagged reports · Top event location is 84% of location-tagged rows .
Serology Tests Used For Infectious Disease… in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Electrode
Electrode, Cutaneous
529 reports
- Serology Test… (this)
Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations
527 reports
- Drug-Coated P…
Drug-Coated Peripheral Transluminal Angioplasty Catheter
526 reports
- Display
Display, Cathode-Ray Tube, Medical
525 reports
- Bur, Dental
Bur, Dental
523 reports
- Unit
Unit, X-Ray, Extraoral With Timer
521 reports
What this shows Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations carries 527 MAUDE reports, ranked #872 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 fell to 61 in 2025, down from an average of 100 in the two years before.
Related Entities for Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations
Top Manufacturers
Event Locations
Nationwide devices with a comparable report-volume footprint
Serology Tests Used For Infectious Disease… 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 (527 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 Serology Tests Used For Infectious Disease… 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 Serology Tests Used For Infectious Disease…; 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.