The STANDARD Q COVID-19 Ag Home Test has not been authorized by the U.S. and cannot be legally imported, distributed, or used in the US
STANDARD Q COVID-19 Ag Home Test. (Credit: Business Wire)
SD Biosensor, Inc., a global in-vitro diagnostics company, is voluntarily recalling its STANDARD Q COVID-19 Ag Home Test in the United States, due to confirmed reports that the test kits were illegally imported into the United States. This product is not authorized, cleared or approved by the U.S. Food and Drug Administration (FDA) for distribution or use in the United States. While there has not been confirmed distribution of these tests directly to consumers to date, SD Biosensor, Inc. is issuing this voluntary recall out of an abundance of caution.
STANDARD Q COVID-19 Ag Home Test
The STANDARD Q COVID-19 Ag Home Test has not been authorized by the U.S. and cannot be legally imported, distributed, or used in the U.S. This product is intended for sale in non-U.S. markets only and is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample. It provides only an initial screening test result. The result of this test should not be the sole basis for the diagnosis; confirmatory testing is required.
The recall of the STANDARD Q COVID-19 Ag Home Test shall have no impact on the distribution and use of the FDA Authorized test (COVID-19 At-Home Test) as the authorized test is a different device.
Recommendations for Consumers and Test Users
In the unlikely event that consumers in the United States encounter the ‘STANDARD Q COVID-19 Ag Home Test,’ they are encouraged to discard and avoid any use of the test, as it has not been authorized, cleared or approved by the FDA for use in COVID-19 testing and diagnosis in the United States. Consumers that have used the unauthorized test are strongly encouraged to consider retesting with an FDA authorized or cleared test and to take precautions with regards to results reported.
Any distribution of the ‘STANDARD Q COVID-19 Ag Home Test’ should be reported immediately to SD Biosensor, Inc. and the FDA at the numbers provided below (+82-31-8065-0340 / help.covid19@sdbiosensor.com).
Adverse reactions or quality problems experienced with the use of either product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Source: Company Press Release