Antigens, All Groups, Streptococcus Spp.
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 Class I (lowest regulatory risk tier, general controls), regulated under 21 CFR §866.3740 (Microbiology panel).
FDA MAUDE casebook
openFDA event book Antigens, All Groups, Streptococcus Spp. LIGHT-BOOK · MAUDE
#993 of 1000 · 370 reports · 1994–2026
- BOOK 370 reports
- RANK #993 of 1000
- DEATH 5 death-typed
- INJ 27 injury-typed
- MALF 336 malfunction
- SPAN 1994–2026
- PEAK 2025: 94
- PHOTO Photometric Method
Nearest event-volume peer: Photometric Method, Magnesium (0 report gap)
Antigens, All Groups, Streptococcus Spp. sits #993 of 1000 among tracked device types with 370 MAUDE reports spanning 1994–2026. 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
Antigens, All Groups, Streptococcus Spp. carries 90.8% MALFUNCTION-coded reports, 26.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 1.4% corpus 1.5% · near corpus mean (-0.2 pp)
- INJ 7.3% corpus 30.3% · below corpus mean (-23.0 pp)
- MALF 90.8% corpus 64.8% · above corpus mean (+26.0 pp)
Lead product-problem code False Positive Result is 34% of coded problems · Lead manufacturer BECTON, DICKINSON & CO. (SPARKS) accounts for 62% of manufacturer-tagged reports · Top event location is 88% of location-tagged rows .
Antigens, All Groups, Streptococcus Spp. in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Azo Dye
Azo Dye, Calcium
372 reports
- Multi-Analyte…
Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer
371 reports
- Antigens (this)
Antigens, All Groups, Streptococcus Spp.
370 reports
- Photometric M…
Photometric Method, Magnesium
370 reports
- Light
Light, Surgical, Accessories
369 reports
- Material
Material, Impression
369 reports
What this shows Antigens, All Groups, Streptococcus Spp. carries 370 MAUDE reports, ranked #993 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 94 in 2025, up from an average of 43 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Antigens, All Groups, Streptococcus Spp.
Top Manufacturers
Event Locations
Compare BECTON, DICKINSON & CO. (SPARKS) vs ALERE SAN DIEGO, INC →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Antigens, All Groups, Streptococcus Spp.: 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 (370 here).
Similar death-typed counts
Nearest other device types by death-typed report count (5 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Antigens, All Groups, Streptococcus Spp. 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 Antigens, All Groups, Streptococcus Spp.; 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.