A South Korean diagnostics company is recalling its rapid COVID-19 test kits in the United States because they were illegally imported, according to the U.S. Food and Drug Administration (FDA).
The Standard Q COVID-19 Ag Home Test kits were manufactured by SD Biosensor and distributed throughout the U.S., but the FDA said it has not approved, authorized or cleared these tests.
SD Biosensor, in addition to the recall, is taking steps to investigate how the tests were illegally imported.
The FDA also said the South Korean company has “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 agency is urging anyone who has in their possession one of the illegally imported tests to not use it and throw it away.
For anyone who has already used the recalled test, the FDA is urging these people to retest with an FDA-approved method. You can find a full list of approved rapid kits here.
This is not the first time the FDA has had to recall COVID-19 tests in the past month.
The agency recalled two COVID-19 rapid test kits because they had the possibility of giving false results.
Related stories about COVID-19:
Stop using these 2 COVID rapid tests, FDA warns. They might give false results.
How to get free N95 masks at Walmart, CVS, Walgreens, Rite Aid and other stores
How to get a COVID booster shot at CVS, Walgreens or Rite Aid
The omicron variant symptoms to look out for if you are fully vaccinated
Our journalism needs your support. Please subscribe today to NJ.com
Katherine Rodriguez can be reached at krodriguez@njadvancemedia.com. Have a tip? Tell us at nj.com/tips.