Devices › Covid-19 multi-analyte antigen device
Device brand name · Covid-19 multi-analyte antigen device
Flowflex Plus COVID-19 and Flu A/B Home Test: medical device reports filed with FDA
153 reports name it, 2025–2026. Manufacturer given most often on reports: Acon Laboratories. Product code QMN.
- 153
- device reports naming the brand
- 0% of all MAUDE reports · about 109 a year
- 120
- reports, 12 months to August 2026
- 33 in the 12 months before
- 100%
- classified as malfunction
- 99.7% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
153 medical device reports received by FDA name the brand "Flowflex Plus COVID-19 and Flu A/B Home Test" (covid-19 multi-analyte antigen device); the manufacturer given most often on reports is Acon Laboratories; received from February 2025 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
120 reports arrived in the 12 months to August 2026, up 264% from 33 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 (100%); across all covid-19 multi-analyte antigen device reports (product code QMN) death is recorded in 0% and malfunction in 99.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are unable to obtain readings (53.6%), false negative result (37.9%) and imprecise or erratic results (5.9%). The patient problems coded most often are fever. 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."
Reports by month, five years
Reports by the month FDA received them. 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, as classified on the report
Who filed the report
Grey bar: all 3,857 reports carrying product code QMN. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Unable to obtain readings | 82 | 53.6% | 2.2% |
| False negative result | 58 | 37.9% | 12.1% |
| Imprecise or erratic results | 9 | 5.9% | 4.5% |
| False positive result | 4 | 2.6% | 77.6% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Fever | 1 | 0.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Flowflex Plus COVID-19 and Flu A/B Home Test | Product code QMN | All MAUDE reports |
|---|---|---|---|
| Reports | 153 | 3,857 | 26,136,888 |
| Share of that pool | — | 4% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 0% | 0.3% | 36.2% |
| Classified as malfunction | 100% | 99.7% | 62.3% |
| Filed by the manufacturer | 100% | 99.8% | 94.9% |
Shares are of reports, not of devices in use. 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."
Other brands with product code QMN
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Sofia2 Flu + SARS Antigen FIA, NS swab | 3,303 | 157 | 0% |
| BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B | 166 | 99 | 0% |
| Ihealth | 362 | 13 | 0% |
| Flowflex COVID-19 Antigen Home Test | 1,312 | 172 | 0% |
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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Flowflex Plus COVID-19 and Flu A/B Home Test reports
How many FDA reports name Flowflex Plus COVID-19 and Flu A/B Home Test?
153 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 120 in the latest 12 months.
What kinds of events are reported?
malfunction (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
unable to obtain readings (53.6%), false negative result (37.9%), imprecise or erratic results (5.9%) and false positive result (2.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Flowflex Plus COVID-19 and Flu A/B Home Test was at fault?
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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.