Covid-19 multi-analyte antigen device: medical device reports filed with FDA

3,857 reports carry this product code, 2020–2026; 5 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.

3,857
reports with this product code: 0% of all MAUDE reports; 387
reports, 12 months to August 2026: 449 in the 12 months before; 99.7%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code QMN is FDA's classification for "Covid-19 multi-analyte antigen device" (unknown panel), a class N device. 3,857 medical device reports carry this product code, 0% of the MAUDE database, from December 2020 to August 2026.

387 reports arrived in the 12 months to August 2026, down 14% from 449 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 (99.7%) and injury (0.3%). 5 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
Sofia2 Flu + SARS Antigen FIA, NS swab	3,303	157	0%	99.9%
BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B	166	99	0%	98.8%
Flowflex Plus COVID-19 and Flu A/B Home Test	153	120	0%	100%
Ihealth	54	13	0%	98.3%
Flowflex COVID-19 Antigen Home Test	2	172	0%	99.2%

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	2,475	64.2%
Quidel Ortho-Clinical Diagnostics	531	13.8%
Bd Rapis Diagnostics Suzhou	260	6.7%
Acon Laboratories	156	4%
Becton Dickinson & Sparks	66	1.7%

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%0

Injury0.3%11

Malfunction99.7%3,846

Other0%0

Not given0%0

Who filed

Manufacturer report99.8%3,849

Voluntary report0.2%8

User facility report0%0

Distributor report0%0

Not given0%0

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

Device problems coded

Device problem (FDA code)	Reports	Share
False positive result	2,992	77.6%
False negative result	466	12.1%
Imprecise or erratic results	172	4.5%
Incorrect, inadequate or imprecise result or readings	113	2.9%
Unable to obtain readings	85	2.2%
Non reproducible results	11	0.3%
Device markings/labelling problema problem with the device markings or label	8	0.2%
Contamination of device ingredient or reagent	2	0.1%
Device contaminated during manufacture or shipping	2	0.1%
Device handling problem	2	0.1%
Inaccurate information	2	0.1%
Insufficient device problem information	2	0.1%
Leak/splashthe device leaked	2	0.1%
Product quality problem	2	0.1%
High readingsreadings were too high	1	0%

Questions about covid-19 multi-analyte antigen device reports

What is product code QMN?

FDA's classification code for "Covid-19 multi-analyte antigen device", class N, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

3,857 reports through August 2026, 387 of them in the latest 12 months.

Which brands appear most often?

Sofia2 Flu + SARS Antigen FIA, NS swab (3,303), BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B (166), Flowflex Plus COVID-19 and Flu A/B Home Test (153), Ihealth (54) and Flowflex COVID-19 Antigen Home Test (2). 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.