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2026 data FDA MAUDE openFDA

Coronavirus Antigen Detection Test System.

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.

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FDA MAUDE casebook

openFDA event book Coronavirus Antigen Detection Test System. MID-BOOK · MAUDE

#112 of 1000 · 26,743 reports · 2020–2026

  • BOOK 26,743 reports
  • RANK #112 of 1000
  • DEATH 5 death-typed
  • INJ 458 injury-typed
  • MALF 26,247 malfunction
  • SPAN 2020–2026
  • PEAK 2022: 13,075
  • PHOTO Stapler, Surgical

Nearest event-volume peer: Stapler, Surgical (114 report gap)

Coronavirus Antigen Detection Test System. sits #112 of 1000 among tracked device types with 26,743 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

Coronavirus Antigen Detection Test System. carries 98.1% MALFUNCTION-coded reports, 33.3pp 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 1.7% corpus 30.3% · below corpus mean (-28.6 pp)
  • MALF 98.1% corpus 64.8% · above corpus mean (+33.3 pp)

Lead product-problem code False Positive Result is 41% of coded problems · Lead manufacturer QUIDEL CORPORATION accounts for 57% of manufacturer-tagged reports · Top event location is 85% of location-tagged rows .

Coronavirus Antigen Detection Test System. in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Coronavirus Antigen Detection Test System. carries 26,743 MAUDE reports, ranked #112 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 26,247 (98.1%)
Injury 458 (1.7%)
22 (0.1%)
Other 10 (0.0%)
Death 5 (0.0%)
No answer provided 1 (0.0%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

25,186 (94.1%)
Other 1,307 (4.9%)
Hospitalization 101 (0.4%)
Required Intervention 70 (0.3%)
O 21 (0.1%)
Disability 19 (0.1%)
Life Threatening 17 (0.1%)
H 15 (0.1%)
R 13 (0.0%)
Congenital Anomaly 6 (0.0%)
Death 6 (0.0%)
S 5 (0.0%)
L 4 (0.0%)
D 2 (0.0%)

Top Product Problems

False Positive Result 14,251
No Apparent Adverse Event 9,982
False Negative Result 5,686
Incorrect, Inadequate or Imprecise Result or Readings 2,356
Unable to Obtain Readings 653
Imprecise or Erratic Results 509
Non Reproducible Results 466
Use of Device Problem 231
Insufficient Device Problem Information 137
Improper or Incorrect Procedure or Method 129
No Device Output 102
Product Quality Problem 76
Adverse Event Without Identified Device or Use Problem 62
Device Markings/Labelling Problem 62
Component Missing 53
Defective Device 39
Nonstandard Device 36
Appropriate Device Problem Term/Code Not Available 32
Manufacturing, Packaging or Shipping Problem 32
Output Problem 29

Yearly Trend

20
2020: 1,372
21
2021: 6,561
22
2022: 13,075
23
2023: 3,478
24
2024: 1,406
25
2025: 755
26
2026: 96

Reports fell to 755 in 2025, down from an average of 2,442 in the two years before.

Related Entities for Coronavirus Antigen Detection Test System.

Top Manufacturers

QUIDEL CORPORATION 8,626
ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 5,021
BECTON, DICKINSON & CO. (SPARKS) 1,526

Event Locations

22,790 (85.2%)
I 3,494 (13.1%)
NO INFORMATION 221 (0.8%)
HOME 215 (0.8%)
OTHER 12 (0.0%)
HOSPITAL 6 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 4 (0.0%)
NURSING HOME 1 (0.0%)

Compare QUIDEL CORPORATION vs ABBOTT DIAGNOSTICS SCARBOROUGH, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Coronavirus Antigen Detection Test System.: 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 (26,743 here).

Stapler, Surgical 26,629 System, Thermal Regulating 26,611 Test, Time, Prothrombin 26,539 Wheelchair, Mechanical 26,370

Similar death-typed counts

Nearest other device types by death-typed report count (5 here), distinct from the volume row.

Anesthesia Conduction Kit 5 Antigens, All Groups, Streptococcus Spp. 5 Apparatus, Exhaust, Surgical 5 Bit, Drill 5

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Coronavirus Antigen Detection Test System. 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 Coronavirus Antigen Detection Test System.; 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.