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Check your COVID-19 rapid test packaging carefully to ensure you’re using authorized products and avoid the risk of false results, FDA warns

Authorized versions of the tests can continue to be used, but consumers should check packaging to make sure they do not buy unauthorized tests, the FDA said.

Carol Yepes/Getty Images

  • The FDA urged Americans to check the packaging of rapid tests to avoid false results.
  • The tests had “not been authorized, cleared, or approved by the FDA for distribution or use in the United States”, the FDA said.
  • Authorized versions of the tests can continue to be used, the FDA said.

Americans should carefully check the packaging of COVID-19 rapid tests to ensure they’re not using unauthorized products that could show false results, the Food and Drug Administration has said.

Some rapid antigen tests being sold in the US haven’t been authorized, the FDA warned Tuesday.

The use of unauthorized tests could result in people wrongly believing that they are virus-free and risk getting sick, or inadvertently spreading COVID-19.

The tests could also incorrectly indicate that people have COVID-19, leading to individuals assuming their symptoms – which could be indicative of a different illness – don’t need further investigation. The false positives could also cause some individuals to isolate with infected people and contract the disease through contact with them. 

People should avoid certain ACON Laboratories’ Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) tests, specifically those that are packaged in a dark blue box, the FDA said. It also warned that the SD Biosensor Inc. STANDARD Q COVID-19 Ag Home Tests should not be used, while certain Celltrion USA Inc. DiaTrust COVID-19 Ag Rapid Tests – specifically those that come in in green and white packaging – should also be avoided.

“This test has not been authorized, cleared, or approved by the FDA for distribution or use in the United States,” it said in all three cases. It added that it was concerned about the risk of false results when using the unauthorized test.

People can still use the authorized versions of the tests, but should check the packaging first to ensure they are using approved products, the FDA said. Images of the unauthorized products are published on its website.

All three companies have issued a recall for any unauthorized test distributed in the US, it said. There hadn’t been any reports of injuries or death from using the unauthorized tests, it added.

US President Joe Biden said Tuesday in his State of the Union Address that COVID-19 testing formed a part of an overarching plan for America to “stay on guard” to combat the virus. 

“We have made hundreds of millions of tests available for you to order for free,” he said. “You can order more from covidtests.gov starting next week,” he said.

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