FDA announces recall of illegally imported COVID-19 test
SD Biosensor said it has initiated an investigation to determine how the product was illegally imported into the U.S.
Photo: seksan MonKhonkhamsao/Getty Images
South Korean diagnostics company SD Biosensor has recalled its COVID-19 at-home tests after news broke that the kits were being imported into the U.S. illegally, according to an announcement from the U.S. Food and Drug Administration.
SD Biosensor voluntarily recalled the Standard Q "due to confirmed reports that the test kits were illegally imported into the United States," the company announced. The Standard Q at-home COVID-9 test is not authorized, cleared or approved by the FDA for distribution or use within the U.S.
"While there is no known distribution of these tests directly to consumers, SD Biosensor Inc. is issuing this voluntary recall out of an abundance of caution," the company said via statement.
The rapid chromatographic immunoassay test detects SARS-CoV-2, the virus that causes COVID-19, through a nasal swab, and provides an initial screening-test result. The company cautions that the test should not be the sole basis for diagnosis.
The FDA is recommending that, in the "unlikely event" that U.S. consumers encounter the test, they discard and avoid any use of the test. The agency suggested that anyone who has used the test should consider retesting with an FDA-authorized or cleared coronavirus test.
WHAT'S THE IMPACT?
If a non-FDA-approved test becomes widespread in the U.S., it may potentially complicate an already complex pandemic response, since consumers may not be able to trust the results of such tests.
Perhaps recognizing this, SD Biosensor has initiated an investigation to determine how the product was illegally imported to the U.S. Distributors, or anyone who illegally imported the products initially sold outside the U.S., will be ordered to stop the illegal activity and initiate an immediate product recall, the company said.
SD Biosensor "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 company said.
The company also announced publicly that if such illegal importations are discovered in the future, the responsible individuals or distributors will face strict legal action and liabilities for damages.
THE LARGER TREND
While this particular test has been recalled, testing in general is still seen as a vital component in controlling the spread of the coronavirus. In fact, people covered either by original Medicare or Medicare Advantage will be able to get over-the-counter COVID-19 tests at no cost starting in the early spring.
Under the new initiative, Medicare beneficiaries will be able to access up to eight over-the-counter COVID-19 tests per month for free. Tests will be available through eligible pharmacies and other participating entities. This policy will apply to COVID-19 over-the-counter tests approved or authorized by the FDA.
This is the first time Medicare has covered an over-the-counter test at no cost to beneficiaries.
The federal government announced last month that it was requiring insurance companies and group health plans to cover the cost of over-the-counter at-home COVID-19 tests for people with private health insurance.
Until spring, people with Medicare can access free tests through a number of channels by requesting four free over-the-counter tests for home delivery at covidtests.gov, accessing tests through healthcare providers at more than 20,000 free testing sites nationwide, and accessing lab-based polymerase chain reaction (PCR) tests and antigen tests performed by a laboratory, when the test is ordered by a physician, nonphysician practitioner, pharmacist or other authorized healthcare professional at no cost.
Twitter: @JELagasse
Email the writer: jeff.lagasse@himssmedia.com
