Flowflex Covid-19 Antigen Home Test

The Flowflex Covid-19 Antigen Home Test

Flowflex Covid-19 Antigen Home Test: The Food and Drug Administration of the United States (FDA) is issuing a caution to the general public to refrain from using certain ACON COVID-19 tests, which are manufactured by ACON Biotech (Hangzhou) Co., Ltd. The Flow flex SARS-CoV-2 Antigen Rapid Test (Self-Testing) that is sold by ACON Biotech and comes in a box that is a dark blue color should not be used by any individuals (see images below). The Food and Drug Administration (FDA) has not given its authorization, clearance, or approval for this test to be distributed or used in the United States. The Food and Drug Administration is concerned about the possibility of obtaining inaccurate findings when utilizing this unapproved test.

The Food and Drug Administration has not received any reports of injuries, adverse health outcomes, or fatalities that have been linked to the unlawful use of the ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing).

Check the packaging of your ACON Flowflex COVID-19 test and see if it matches the one shown in the image above. Do not use the ACON Biotech Flow flex SARS-CoV-2 Antigen Rapid Test (Self-Testing) if it is packaged in the dark blue container as described in the previous paragraph.

Users and careers will be put to the test: If you believe that you were tested with the ACON Biotech Flow flex SARS-CoV-2 Antigen Rapid Test (Self-Testing), and you have questions about the findings of your test, you should discuss them with a health care practitioner.

Providers of healthcare and those in charge of organizing testing programs: If an antigen test was performed on your patient using the ACON Biotech Flow flex SARS-CoV-2 Antigen Rapid Test (Self-Testing) less than two weeks ago, you should strongly consider retesting your patient using an FDA-authorized SARS-CoV-2 diagnostic test if you have any reason to suspect that the result was inaccurate. It is not essential to retest if the initial testing was completed over two weeks earlier and that there is no cause to think that the individual is now infected with SARS-CoV-2.

Notify the Food and Drug Administration (FDA) of any issues you encounter while using the Flow flex SARS-CoV-2 Antigen Rapid Test (Self-Testing), including any suspected false findings. Please go to the section on Reporting Problems in Your Test.

Test Description

Flowflex Covid-19 Antigen Home Test: A nasal swab sample is used in the unapproved ACON Biotech Flow flex SARS-CoV-2 Antigen Rapid Test (Self-Testing) in order to detect proteins, which are referred to as antigens, from the SARS-CoV-2 virus, which is the virus that causes COVID-19. A dark blue box with white lettering and symbols in the lower right corner of the box, including the letters “CE” and the name ACON Biotech (Hangzhou) Co., Ltd. identified on the outer box label, are characteristics of the unauthorized test. The label on the outer box also includes the company’s name.

The ACON Laboratories Flow flex COVID-19 Antigen Home Test, which was given approval by the FDA on October 4, 2021, is not the focus of this Safety Communication and can be used normally going forward.

Risks Of False Test Results

Flowflex Covid-19 Antigen Home Test: While a person gets a result on an antigen test that says they do not have COVID-19 when in reality they do have COVID-19, this is referred to as a false-negative antigen test result. A false-negative result may lead to a delayed diagnosis or improper treatment of SARS-CoV-2, either of which may cause patients to suffer harm, including serious sickness and death. When people are placed together in health care, long-term care, as well as other facilities based on these false test findings, this can lead to increased transmission of the SARS-CoV-2 virus. False-negative results can also contribute to greater spread of the virus. It is possible that efforts to limit exposure to an infected individual, such as isolating persons, limiting contact with friends and relatives, or limiting access to places of employment, will not be implemented when false negative test results are received. For example, a person may not be isolated.

Flowflex Covid-19 Antigen Home Test: A result of a test for an antigen that is incorrectly positive indicates that the person being tested does not in fact have the COVID-19 virus. This is referred to as a false-positive antigen test result. A false-positive result may cause a delay in both the accurate diagnosis and adequate treatment for the true cause of a person’s illness, which may be this other life-threatening disease that is not COVID-19. This may cause the person’s condition to worsen or even become fatal. When persons who are thought to be positive for SARS-CoV-2 are housed together, false-positive test findings have the potential to accelerate the virus’s ability to spread.

Leave a Reply

Your email address will not be published.