South Korean COVID test kits recalled after illegal importation to U.S.
The South Korean diagnostics company SD BIOSENSOR recalled one of its COVID-19 test kits due to confirmed reports that the tests were illegally imported into the United States.
The FDA posted an official recall notice on its website, saying that SD BIOSENSOR voluntarily pulled the product as an "abundance of caution."
It's an item called STANDARD Q COVID-19 Ag Home Test which the FDA has not approved or cleared for any circumstances in the U.S., including emergency use. The test is a nasal swab intended to provide users with initial screening test result for COVID-19.
SD BIOSENSOR said in its official recall statement that American consumers had 'unlikely' encountered the product, but should throw the test away in the event they purchased or received one.
Users who may have taken the COVID-19 test have been urged by both SD BIOSENSOR and the FDA to be retested with approved kits since the product is not seen by the U.S. Government as a legitimate way of determining infection.
The FDA provided the public with a list of approved COVID-19 tests that can be found here.
The diagnostics company had began an investigation this week after claiming it had no idea how the tests were imported to America. It said it will begin taking "appropriate measures" to prevent further attempts at illegal importation of the unauthorized tests by strengthening its contract terms and enforcing those agreements with its distributors.
SD BIOSENSOR also promised to bring legal action against any entity or individuals responsible for the illegal importation of the kits.
There is no word on how many tests were shipped or distributed in the U.S. but the public should continue to avoid that specific brand of test.
