The U.S. Food and Drug Administration has posted a recall for at-home COVID-19 tests that were imported illegally and not approved by public health officials. The tests were manufactured by the South Korean diagnostics company SD Biosensor, and are labeled “Standard Q COVID-19 Ag Home Tests.” The company posted the recall itself in cooperation with the FDA, but there is an investigation underway to find out how they were brought into the country.
According to the recall published by the FDA, SD Biosensor tests were not “authorized, cleared or approved by the FDA” for use within the U.S. Consumers who are in possession of these tests are “strongly encouraged to consider retesting with an FDA authorized or cleared test.” However, SD Biosensor claims that “there is no known distribution of these tests directly to consumers,” so they may not have been sold at the direct consumer level like other tests.
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“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,” the recall continues. “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.”
The recall makes no mention of refunds available for the recalled product – probably because they were not sold directly to consumers. Typically customers need to bring recalled products back to the point of purchase to claim their refund. If customers were administered an SD Biosensor test at a medical facility it was most likely free of charge.
At-home COVID-19 tests have become a central part of the strategy for avoiding infection and slowing the spread of the virus. Those who are vaccinated and boosted can do little else besides get tested after exposures and avoid high-risk situations when possible. The Centers for Disease Control and Prevention has an FAQ page about at-home tests, which notes that face masks, hand-washing and physical distancing are still important measures as well.
The CDC also notes that “A negative self-test result means that the test did not detect the virus that causes but it does not rule out a COVID-19 infection. A single negative self-test result may not reliable, especially if you have symptoms associated with COVID-19. If your result is negative, repeating the self-test within a few days, with at least 24 hours between tests, will increase the confidence that you are not infected with the virus causing COVID-19.”
In general, COVID-19 infection rates are now falling in the U.S., but the country still suffered 3,958 deaths on Friday. Visit the CDC’s website for the latest information on how to keep yourself and your community safe.
