Reagent, Coronavirus Serological
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 Reagent, Coronavirus Serological LIGHT-BOOK · MAUDE
#560 of 1000 · 1,550 reports · 2020–2024
- BOOK 1,550 reports
- RANK #560 of 1000
- DEATH 0 death-typed
- INJ 4 injury-typed
- MALF 1,544 malfunction
- SPAN 2020–2024
- PEAK 2020: 860
- PHOTO Modular Electromechan…
Nearest event-volume peer: Modular Electromechanical Surgical System (2 report gap)
Reagent, Coronavirus Serological sits #560 of 1000 among tracked device types with 1,550 MAUDE reports spanning 2020–2024. 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
Reagent, Coronavirus Serological carries 99.6% MALFUNCTION-coded reports, 34.8pp 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 0.3% corpus 30.3% · below corpus mean (-30.0 pp)
- MALF 99.6% corpus 64.8% · above corpus mean (+34.8 pp)
Lead product-problem code False Positive Result is 46% of coded problems · Lead manufacturer SIEMENS HEALTHCARE DIAGNOSTICS, INC. accounts for 58% of manufacturer-tagged reports · Top event location I is 88% of location-tagged rows .
Reagent, Coronavirus Serological in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Barrier
Barrier, Absorbable, Adhesion
1,558 reports
- Modular Elect…
Modular Electromechanical Surgical System
1,552 reports
- Reagent (this)
Reagent, Coronavirus Serological
1,550 reports
- Catheter
Catheter, Umbilical Artery
1,545 reports
- Toothbrush
Toothbrush, Manual
1,544 reports
- Equipment
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
1,540 reports
What this shows Reagent, Coronavirus Serological carries 1,550 MAUDE reports, ranked #560 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 6 in 2023, down from an average of 340 in the two years before.
Related Entities for Reagent, Coronavirus Serological
Top Manufacturers
Event Locations
Compare SIEMENS HEALTHCARE DIAGNOSTICS, INC. vs ORTHO-CLINICAL DIAGNOSTICS →
Nationwide devices with a comparable report-volume footprint
Reagent, Coronavirus Serological 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 (1,550 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 Reagent, Coronavirus Serological 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 Reagent, Coronavirus Serological; 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.