![]() ![]() Do not use the STANDARD Q COVID-19 Ag Home Test.distributors and customers take the following actions: People who were tested for COVID-19 using the SD Biosensor STANDARD Q COVID-19 Ag Home Test.Health care providers and other organizations who used the SD Biosensor STANDARD Q COVID-19 Ag Home Test to test patients for COVID-19.Distributors of the SD Biosensor STANDARD Q COVID-19 Ag Home Test.On March 1, 2022, FDA issued a Safety Communication, Do Not Use SD Biosensor STANDARD Q COVID-19 Ag Home Tests, warning users to stop using these tests. Use of the affected product could cause serious adverse health consequences and death. There have been no reports of injuries, adverse health consequences, or death associated with the use of the SD Biosensor STANDARD Q COVID-19 Ag Home Test. False-positive results occur when the test says the person has SARS-CoV-2 virus present, but they are not infected. False negative results are when the test does not detect the SARS-CoV-2 virus but the person is actually infected. This means there is a risk of both false-negative and false-positive test results. customers without authorization, clearance, or approval from the FDA.Īs this test was not authorized, cleared, or approved by the FDA, there is not sufficient data demonstrating that the test's performance is accurate. is recalling its STANDARD Q COVID-19 Ag Home Tests because these tests were distributed to U.S. Note: This recall does not apply to the SD Biosensor COVID-19 At-Home Test (also an antigen test), which was authorized by the FDA on December 24, 2021, and is distributed by Roche Diagnostics. This test is not authorized, cleared, or approved by the FDA for marketing or distribution in the United States. The SD Biosensor STANDARD Q COVID-19 Ag Home Test uses a nasal swab sample to detect proteins, called antigens, from SARS-CoV-2, the virus that causes COVID-19. Date Initiated by Firm: January 31, 2022.Devices Recalled in the U.S.: Up to 397,700 units.Distribution Dates: Augto January 30, 2022.Product Codes and Lot Numbers: See recall database entry. ![]()
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