STANDARD Q COVID-19 Ag Home Test Recall Overview:
- Who: Global in-vitro diagnostics company SD Biosensor, Inc. has issued a voluntary recall of its STANDARD Q COVID-19 Ag Home Test.
- Why: The company has confirmed reports that the test kits were illegally imported into the United States.
- Where: The recall applies to the United States.
A global diagnostics company is recalling one of its brands of at-home COVID-19 tests after discovering the tests were illegally imported into the United States.
SD Biosensor, Inc issued the voluntary recall through the U.S. Food & Drug Administration (FDA) on Jan. 31. The recall applies to all of its STANDARD Q COVID-19 Ag Home Tests.
According to the company, it confirmed the test kits were illegally imported into the United States.
“The STANDARD Q COVID-19 Ag Home Test is not authorized, cleared or approved by the FDA for distribution or use in the United States,” the company says.
SD Biosensor said there was no known distribution of the tests directly to consumers, but it issued the recall out of an abundance of caution.
“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,” the recall notice says.
Consumers that have used the test are “strongly encouraged” to consider retesting with an FDA authorized or cleared test.
The company is not currently facing legal action over the recall, but Top Class Actions follows recalls closely as they sometimes end in class action lawsuits.
SD BIosensor Has Initiated Investigation To Determine How Product Was Illegally Imported Into U.S.
SD Biosensor, Inc. says it considers the illegal importation to be a “grave matter.”
It says it 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,” the recall says.
The company is also taking measures to prevent future attempts at illegal importation of unauthorized tests by strengthening contract terms and its enforcement with its distributors.
It added that if illegal importations are discovered in the future, “the responsible individuals and distributors will face strict legal action and liabilities for damages.”
The news comes after approximately 200,100 Flowflex SARS-COV-2 Antigen Rapid Tests (Self-Testing) have been recalled by the FDA as the tests were never granted approval by the agency.
Does it concern you that illegally imported tests may be available on the market? Let us know in the comments!
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