The Flowflex COVID-19 Antigen Home Test is manufactured by ACON Laboratories. ACON also makes Distinct home pregnancy tests and On Call blood glucose meters.

As with other over-the-counter COVID-19 tests, Flowflex requires you to collect a sample from your nasal passage using the sterile swab provided. According to the company, Flowflex delivers results in 15 minutes and is safe to use for children as young as 2 years old.

One of the other tests developed by ACON — the Flowflex SARS-CoV-2 antigen rapid test (self-test) — has been distributed in the United States as a counterfeit product, the agency said FDA.

This test is only approved for sale in Europe and other markets and ACON has not imported it into the United States.

In early 2022, the product was recalled in the United States. It cannot be legally imported, distributed, or used in the United States because it has not been approved, cleared, or authorized by the FDA.

This test differs from the Flowflex COVID-19 Antigen Home Test, which is still available in the US and has received an EUA from the FDA.

The FDA also released a security communication Advise people against using certain ACON COVID-19 tests, such as the Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Test), packaged in a dark blue box.

While there have been no reports of death, injury, or adverse health outcomes, the FDA is concerned about the risk of false results from using this unauthorized test.

Be sure to check the packaging before purchasing a Flowflex test. The Flowflex COVID-19 Antigen Home Test, which comes in a white box, is FDA cleared for use in the United States.

It is important to use tests that are authorized or cleared by the FDA. COVID-19 antigen testing in the United States that is not FDA-approved can pose a significant risk. Using these tests can lead to inaccurate test results such as false negative or false positive results.

False-negative results could lead to delayed diagnosis or inappropriate treatment of SARS-CoV-2. This could harm people by unknowingly spreading the virus, potentially causing serious illness and death.

False positive antigen test results can cause a delay in both correctly diagnosing and treating a person’s underlying cause of illness, which could be a virus other than SARS-CoV-2.

Although the Flowflex COVID-19 Antigen Home Test is not officially FDA cleared, the FDA has granted it one EUA. Under an EUA, the FDA can authorize the use of unapproved medical devices if the benefits appear to outweigh the risks.

Online reviews of Flowflex’s antigen home test are mostly positive.

Reviewers report that the test is very accurate, but note that it is very important to follow the instructions carefully to get accurate results. Others appreciate the quick results and find the test affordable and convenient.

Since the Flowflex SARS-CoV-2 antigen rapid test (Self-Testing) has been recalled in the United States, it is no longer sold online and there are very few reviews directly relating to it.

Overall, ACON Laboratories gets an average of 4 stars on sites like CVS and Target. While some customers say the test was easy and quick to use, others complain that their tests were missing parts that made the product impossible to use.

The FDA has received no reports of death, injury, or adverse health outcomes related to these tests. However, one Flowflex product has been recalled in the US, meaning it is unsafe to use.

That FDA advises all consumers who received the Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Test) with the blue box in the US to discontinue use and discard the product.

The FDA encourages you to report any issues through the MedWatch voluntary reporting form. This form is a place for consumers to report observed or suspected adverse events for medicinal products for human use. These reports help the FDA identify risks for medical devices.

The Flowflex COVID-19 Antigen Home Test is available from many online retailers such as:

If you’d rather opt for an at-home COVID-19 test that isn’t performed by Flowflex, here are a few other options that are also Healthline-approved.

Everlywell COVID-19 Test Home Collection Kit DTC

Price: $109

With Everlywell’s COVID-19 home test, you can easily test for SARS-CoV-2 infection whether you have symptoms or not. Collect your sample at home (a lower nasal swab) and ship it for free. You will then receive secure digital results within 24 to 48 hours of receiving your sample at the lab.

A telemedicine consultation is available to guide you through your next steps. This FDA-approved test is for people ages 18 and older.

LetsGetChecked Coronavirus Test (COVID-19)

Price: $109

This COVID-19 home test can be ordered online and has free shipping. You can complete the easy-to-follow process of swabbing your sample, then use the provided UPS next-day return label to ship your sample back to the lab.

Once your sample is analyzed, you will receive the results within 24 to 72 hours.

Labcorp OnDemand COVID-19 Test (Home Collection Kit)

Price: $119

Get a home collection COVID-19 PCR test kit from Labcorp and collect your nasal swab before shipping it back to the lab via FedEx drop-off.

The lab will perform a PCR test on your sample and provide the results within 1 to 2 days. This test is safe for people 2 years and older.

Why was Flowflex recalled?

The Flowflex SARS-CoV-2 Rapid Antigen Test (Self-Test) has not been authorized, cleared, or cleared by the FDA for distribution or use in the United States. The FDA is concerned about the risk of false results from using this unauthorized test.

Meanwhile, the Flowflex COVID-19 Antigen Home Test has not been approved by the FDA but has received an EUA. This means it is safe to use.

What are the consequences of a false negative COVID-19 test?

A false negative result could lead to this delayed diagnosis or inappropriate treatment of SARS-CoV-2, which can lead to serious illness.

False-negative results can also lead to further spread of SARS-CoV-2 as measures may not be taken to limit exposure to people with the virus.

How accurate are at-home COVID-19 tests?

Home COVID-19 tests detect current infection and are noisy Centers for Disease Control and Prevention (CDC). Some home rapid antigen tests are available 85 percent accurate in detecting positive cases. You are more likely to get a false negative than a false positive.

Although the Flowflex COVID-19 Antigen Home Test is not FDA cleared, the FDA has cleared it, meaning it is safe to use.

However, the Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Test) has been recalled in the United States because it is not FDA cleared or authorized.

If you want additional options for a home COVID-19 test, try one of our recommended alternatives.