Coronavirus antigen detection test system.: medical device reports filed with FDA

26,765 reports carry this product code, 2020–2026; 19 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

26,765
reports with this product code: 0.1% of all MAUDE reports; 243
reports, 12 months to August 2026: 1,229 in the 12 months before; 98.1%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code QKP is FDA's classification for "Coronavirus antigen detection test system." (unknown panel), a class N device. 26,765 medical device reports carry this product code, 0.1% of the MAUDE database, from June 2020 to August 2026.

243 reports arrived in the 12 months to August 2026, down 80% from 1,229 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (98.1%) and injury (1.7%). 19 brand names with a page on this site carry this code; the brands table is ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Quickvue At-Home Otc Covid-19 Test	4,714	30	0%	99.7%
Sofia Sars Antigen Fia Ns Swab	3,865	2	0%	100%
Ellume Covid-19 Home Test	2,999	0	0%	100%
Lumiradx Sars-Cov-2 Ag Test Strip Kit	2,150	0	0%	100%
Binaxnow Covid-19 Ag Card	2,076	0	0%	97.5%
Bd Rapid Detection Of Sars-Cov-2 Veritor	1,580	0	0%	99.4%
Flowflex COVID-19 Antigen Home Test	1,302	172	0%	99.2%
Binaxnow Covid-19 Ag Self Test 2ct	1,227	53	0.1%	96.5%
Quickvue Sars Antigen Test	785	0	0%	99.7%
Binaxnow Covid-19 Antigen Self Test	624	0	0%	89.6%
Bd Rapid Detection Of Sars-Cov-2 Veritor Assay	520	0	0%	100%
Binaxnow Covid-19 Antigen Self-Test	487	0	0%	89.9%
Ellume Covid-19 Home Test Kit	470	0	0%	100%
Binax Now Covid-19 Ag Card	422	0	0%	94.1%
Ihealth	299	13	0%	98.3%
Bd Veritor At-Home Covid-19 Test	276	0	0%	97.8%
Cvs Health At Home Covid-19 Test Kit	263	11	0%	94.7%
Covid-19 At-Home Test	181	0	0%	99.4%
Id Now Covid-19 Assay	1	0	0%	96.8%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Quidel	8,813	32.9%
Abbott Diagnostics Scarborough	5,437	20.3%
Ellume	3,555	13.3%
Lumiradx UK	2,150	8%
Becton Dickinson & Sparks	1,521	5.7%
Acon Laboratories	1,446	5.4%
Bd Rapis Diagnostics Suzhou	832	3.1%
Quidel Ortho-Clinical Diagnostics	809	3%
Becton Dickinson	73	0.3%
Bd	63	0.2%
Ortho-Clinical Diagnostics	31	0.1%
Becton Dickinson And	14	0.1%
Siemens Healthcare Diagnostics	14	0.1%
Abbott Laboratories	7	0%
Becton Dickinson Infusion Therapy Systems	5	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death0%5

Injury1.7%458

Malfunction98.1%26,269

Other0%10

Not given0.1%23

Who filed

Manufacturer report94.9%25,397

Voluntary report4.2%1,122

User facility report0%0

Distributor report0.9%245

Not given0%1

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
False positive result	14,252	53.2%
False negative result	5,686	21.2%
Incorrect, inadequate or imprecise result or readings	2,356	8.8%
Unable to obtain readings	673	2.5%
Imprecise or erratic results	509	1.9%
Non reproducible results	466	1.7%
Insufficient device problem information	137	0.5%
Improper or incorrect procedure or method	129	0.5%
No device output	102	0.4%
Product quality problem	75	0.3%
Device markings/labelling problema problem with the device markings or label	62	0.2%
Component missing	53	0.2%
Defective devicethe device was defective	39	0.1%
Nonstandard device	36	0.1%
Manufacturing, packaging or shipping problem	31	0.1%
Output problem	29	0.1%
Expiration date error	24	0.1%
Patient-device incompatibilitythe device did not suit the patient	16	0.1%
Defective component	13	0%
Leak/splashthe device leaked	13	0%

Questions about coronavirus antigen detection test system. reports

What is product code QKP?

FDA's classification code for "Coronavirus antigen detection test system.", class N, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

26,765 reports through August 2026, 243 of them in the latest 12 months.

Which brands appear most often?

Quickvue At-Home Otc Covid-19 Test (4,714), Sofia Sars Antigen Fia Ns Swab (3,865), Ellume Covid-19 Home Test (2,999), Lumiradx Sars-Cov-2 Ag Test Strip Kit (2,150) and Binaxnow Covid-19 Ag Card (2,076). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." Brands differ in how many are in use, how long they have been sold and how reports are collected.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.