Reagents, 2019-Novel Coronavirus Nucleic Acid
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 Reagents MID-BOOK · MAUDE
#133 of 1000 · 20,135 reports · 2020–2026
- BOOK 20,135 reports
- RANK #133 of 1000
- DEATH 8 death-typed
- INJ 303 injury-typed
- MALF 19,816 malfunction
- SPAN 2020–2026
- PEAK 2021: 7,300
- PHOTO Port & Catheter
Nearest event-volume peer: Port & Catheter, Implanted, Subcutaneous, Intravascular (50 report gap)
Reagents, 2019-Novel Coronavirus Nucleic Acid sits #133 of 1000 among tracked device types with 20,135 MAUDE reports spanning 2020–2026. 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 →
Event-type mix vs corpus
Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.
- DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
- INJ 1.5% corpus 30.4% · below corpus mean (-28.9 pp)
- MALF 98.4% corpus 64.5% · above corpus mean (+33.9 pp)
Lead product-problem code False Positive Result is 49% of coded problems · Lead manufacturer ABBOTT DIAGNOSTICS SCARBOROUGH, INC. accounts for 53% of manufacturer-tagged reports · Top event location is 65% of location-tagged rows .
Reagents in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Reagents (this)
Reagents, 2019-Novel Coronavirus Nucleic Acid
20,135 reports
- Port & Cathet…
Port & Catheter, Implanted, Subcutaneous, Intravascular
20,085 reports
- Catheter
Catheter, Intravascular, Diagnostic
19,752 reports
- Duodenoscope…
Duodenoscope And Accessories, Flexible/Rigid
19,614 reports
- System
System, Image Processing, Radiological
19,390 reports
- Orthopedic St…
Orthopedic Stereotaxic Instrument
19,167 reports
What this shows Reagents, 2019-Novel Coronavirus Nucleic Acid carries 20,135 MAUDE reports, ranked #133 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
Related Entities for Reagents, 2019-Novel Coronavirus Nucleic Acid
Top Manufacturers
Event Locations
Compare ABBOTT DIAGNOSTICS SCARBOROUGH, INC. vs ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG →
Nationwide devices with similar MAUDE profiles
Two openFDA-derived peer sets for Reagents, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (20,135 here).
Similar death-typed counts
Nearest other device types by death-typed report count (8 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Reagents 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 Reagents; 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.