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SD BIOSENSOR Issues Notification of Voluntary Recall of Non-EUA Authorized ‘STANDARD Q COVID-19 Ag Home Test’ in the United States

2022年02月01日 AM10:09
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SUWON, South Korea

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.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220131005964/en/

STANDARD Q COVID-19 Ag Home Test (Photo: Business Wire)

STANDARD Q COVID-19 Ag Home Test (Photo: Business Wire)

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.

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Measures to Prevent Further Illegal Importation

SD Biosensor, Inc. considers illegal importation to be a grave matter. In addition to issuing a voluntary recall for the ‘STANDARD Q COVID-19 Ag Home Test,’ SD Biosensor, Inc. has initiated an investigation to determine how the product was illegally imported into the United States. Distributors or individuals who illegally imported the products initially sold outside the United States will be ordered to stop the illegal activity and initiate an immediate product recall.

SD Biosensor, Inc. is taking appropriate measures to prevent further attempts at illegal importation of unauthorized tests by strengthening contract terms and their enforcement with its distributors. In addition, the company announced publicly that if such illegal importations are discovered in the future, the responsible individuals/distributors will face strict legal action and liabilities for damages.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220131005964/en/

CONTACT

Evie Baik (pr@sdbiosensor.com)

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