Nucleic-Acid 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 Nucleic-Acid Tests Used For Infectious Dise… LIGHT-BOOK · MAUDE
#911 of 1000 · 475 reports · 2017–2026
- BOOK 475 reports
- RANK #911 of 1000
- DEATH 0 death-typed
- INJ 55 injury-typed
- MALF 419 malfunction
- SPAN 2017–2026
- PEAK 2025: 351
- PHOTO Heart-Valve, Allograft
Nearest event-volume peer: Heart-Valve, Allograft (1 report gap)
Nucleic-Acid Tests Used For Infectious Disease Screening Of Blood And Plasma Donations sits #911 of 1000 among tracked device types with 475 MAUDE reports spanning 2017–2026. 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
Nucleic-Acid Tests Used For Infectious Dise… carries 88.2% MALFUNCTION-coded reports, 23.4pp 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 11.6% corpus 30.3% · below corpus mean (-18.7 pp)
- MALF 88.2% corpus 64.8% · above corpus mean (+23.4 pp)
Lead product-problem code Incorrect, Inadequate or Imprecise Result or Readings is 26% of coded problems · Lead manufacturer ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG accounts for 99% of manufacturer-tagged reports · Top event location is 96% of location-tagged rows .
Nucleic-Acid Tests Used For Infectious Dise… in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Enzyme Immuno…
Enzyme Immunoassay, Digoxin
478 reports
- Scaffold
Scaffold, Dissection Repair
478 reports
- Agents
Agents, Embolic, For Treatment Of Uterine Fibroids
477 reports
- Nucleic-Acid… (this)
Nucleic-Acid Tests Used For Infectious Disease Screening Of Blood And Plasma Donations
475 reports
- Heart-Valve
Heart-Valve, Allograft
474 reports
- Microscope
Microscope, Surgical
473 reports
What this shows Nucleic-Acid Tests Used For Infectious Disease Screening Of Blood And Plasma Donations carries 475 MAUDE reports, ranked #911 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 351 in 2025, up from an average of 12 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Nucleic-Acid Tests Used For Infectious Disease Screening Of Blood And Plasma Donations
Top Manufacturers
Event Locations
Compare ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG vs Roche Molecular Systems, Inc. - Branchburg →
Nationwide devices with a comparable report-volume footprint
Nucleic-Acid Tests Used For Infectious Dise… 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 (475 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 Nucleic-Acid Tests Used For Infectious Dise… 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 Nucleic-Acid Tests Used For Infectious Dise…; 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.