MONDAY, March 23, 2020 — Fake in-home test kits for coronavirus are being marketed in the United States and could pose serious health risks, the U.S. Food and Drug Administration says.
“We want to alert the American public that, at this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19,” said FDA Commissioner Dr. Stephen Hahn and Associate Commissioner for Regulatory Affairs Judith McMeekin.
They said the FDA sees the public health value in expanding availability of safe, accurate tests for COVID-19 that may include home collection and is actively working with test developers.
“Fraudulent health claims, tests and products can pose serious health risks,” Hahn and McMeekin warned in an agency news release. “They may keep some patients from seeking care or delay necessary medical treatment.”
If you think you have symptoms of COVID-19, the FDA said you should follow U.S. Centers for Disease Control and Prevention guidelines and talk to your health care provider. He or she will advise you about whether you should get tested and how to receive an appropriate test.
“The FDA will take appropriate action to protect consumers from bad actors who take advantage of a crisis to deceive the public by marketing tests that pose risks to patient health,” Hahn and McMeekin said. “This may include issuing warning letters, seizures or injunctions.”
The agency has issued warning letters to companies selling and promoting fake test kits. It has also stepped up enforcement at ports of entry, including international mail facilities, to prevent fake kits from other countries from getting into the United States.
Consumers who know about fake test kits for COVID-19 should report them to the FDA, the agency said.
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Posted: March 2020