FDA Recalls Brand of COVID-19 Tests Over Risk of False Results

01/16/2022 12:32 pm EST

On Tuesday, the U.S. Food and Drug Administration issued a sudden recall for LuSys Laboratories' COVID-19 tests. The at-home tests from this company may be extremely inadequate, the agency believes. The FCA wants sales of these tests to cease and urges Americans not to make health decisions based on them.

LuSys Laboratories has been selling both antigen and antibody tests, also under the company names Luscient Diagnostics or Vivera Pharmaceuticals, or with the trade name EagleDx. The FDA announced on Tuesday that "the performance of these tests has not been adequately established and the FDA believes there is likely a high chance of false results when using these tests. Neither test has been authorized, cleared or approved by the FDA for distribution or use in the United States."

Bypassing the FDA certification phase, these tests were distributed under all the names listed above to both laboratories and individuals for use at home or at medical facilities. The FDA is hoping to get the word out quickly so that the tests can be taken out of circulation before false results impact public health too severely. The agency did not explain how these companies were allowed to bypass their checks.

The FDA advises individuals to disregard at-home test results if they used a LuSys Laboratories COVID-19 Antigen Test or an IgG/IgM Antibody Test. It also advises people who got these tests at a doctor's office, pharmacy or other facility to contact their healthcare provider and probably seek a different test.

As for healthcare professionals, the FDA said that they should strive to re-test patients with a different product if possible. However, it said that patients tested more than two weeks ago do not need to be re-tested. Any problems with LuSys Laboratories COVID-19 tests should be reported directly to the FDA using this form.

Of course, a false negative COVID-19 test result carries extremely high risks, as a person could then go out in public and infect countless other people with the virus. They could also put their family, friends and colleagues at undue risk. The FDA notes that a false positive should be reported as well, since it could force a person to miss important life events without reason.

The FDA urges people to spread the word about LuSys COVID-19 tests and it promises to keep the public updated on this recall. The agency can be reached by phone at 800-638-2041 or 301-796-7100, or by e-mail at DICE@FDA.HHS.GOV.

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