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
#139 of 1000 · 20,142 reports · 2020–2026
- BOOK 20,142 reports
- RANK #139 of 1000
- DEATH 8 death-typed
- INJ 303 injury-typed
- MALF 19,823 malfunction
- SPAN 2020–2026
- PEAK 2021: 7,300
- PHOTO Catheter
Nearest event-volume peer: Catheter, Intravascular, Diagnostic (14 report gap)
Reagents, 2019-Novel Coronavirus Nucleic Acid sits #139 of 1000 among tracked device types with 20,142 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 →
Malfunction reports run above the device-type norm
Reagents carries 98.4% MALFUNCTION-coded reports, 33.6pp 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 1.5% corpus 30.3% · below corpus mean (-28.8 pp)
- MALF 98.4% corpus 64.8% · above corpus mean (+33.6 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
- Orthopedic St…
Orthopedic Stereotaxic Instrument
20,328 reports
- Reagents (this)
Reagents, 2019-Novel Coronavirus Nucleic Acid
20,142 reports
- Catheter
Catheter, Intravascular, Diagnostic
20,128 reports
- Suture
Suture, Nonabsorbable, Synthetic, Polyethylene
20,010 reports
- Leadless Pace…
Leadless Pacemaker
19,964 reports
- Dorsal Root G…
Dorsal Root Ganglion Stimulator For Pain Relief
19,735 reports
What this shows Reagents, 2019-Novel Coronavirus Nucleic Acid carries 20,142 MAUDE reports, ranked #139 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 370 in 2025, down from an average of 1,900 in the two years before.
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 a comparable volume-and-death footprint
Two openFDA-derived peer sets for Reagents: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (20,142 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.