Date Issued: March 1, 2022
The U.S. Food and Drug Administration (FDA) is warning people not to use the SD Biosensor Inc. STANDARD Q COVID-19 Ag Home Test. The test is not authorized, cleared, or approved by the FDA for distribution or use in the United States. The FDA is concerned about the risk of false results when using this unauthorized test. This unauthorized test may be packaged in a white and magenta box (see image below).
The FDA has not received reports of injuries, adverse health consequences, or death associated with use of the SD Biosensor STANDARD Q COVID-19 Ag Home Test.
Risks of False Test Results
- A false-negative antigen test result means that the test says the person does not have COVID-19 but they actually do have COVID-19. A false-negative result may lead to delayed diagnosis or inappropriate treatment of SARS-CoV-2, which may cause people harm including serious illness and death. False-negative results can also lead to further spread of the SARS-CoV-2 virus, including when people are housed together in health care, long-term care, and other facilities based on these false test results. When false negative test results are received, actions to limit exposure to an infected person might not be taken, such as isolating people, limiting contact with family and friends, or limiting access to places of employment.
For full report :
https://www.fda.gov/medical-devices...vid-19-ag-home-tests-fda-safety-communication
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