FDA recalls COVID-19 testing mark over risk of false results

The United States Food and Drug Administration issued a serious recall for LuSys Laboratories brand COVID-19 testing on Tuesday. The company’s home testing may be grossly insufficient, the agency said. He calls on distributors to stop selling these tests and urges Americans not to make health decisions based on them.

LuSys Laboratories sells antigen and antibody tests, also under the company names Luscient Diagnostics or Vivera Pharmaceuticals, or under the trade name EagleDx. The FDA announced Tuesday that “the performance of these tests has not been sufficiently established and the FDA believes there is likely a high risk of false results when using these tests. No tests have been authorized, licensed, or approved by the FDA for distribution or use in the United States.

Bypassing the FDA certification phase, these tests have been distributed under all of the names listed above to laboratories and individuals for use in the home or in medical facilities. The FDA hopes to get the word out quickly so that the tests can be withdrawn from circulation before the false results too seriously affect public health. The agency did not explain how these companies were allowed to bypass their controls.

The FDA advises individuals to disregard home test results if they have used a LuSys Laboratories COVID-19 antigen test or an IgG / IgM antibody test. He also advises people who have had these tests at a doctor’s office, pharmacy, or other facility to contact their health care provider and likely seek another test.

As for medical professionals, the FDA has said they should make an effort to re-test patients with a different product if possible. However, he said patients tested more than two weeks ago did not need to be retested. Any issues with LuSys Laboratories’ COVID-19 testing should be reported directly to the FDA using this form.

Of course, a falsely negative COVID-19 test result carries extremely high risks, as a person could then go out in public and infect countless others with the virus. They could also put their family, friends and colleagues at risk. The FDA notes that a false positive should also be reported, as it could force a person to miss important life events for no reason.

The FDA urges people to publicize LuSys COVID-19 tests and promises to keep the public apprised of this recall. The agency can be reached by phone at 800-638-2041 or 301-796-7100, or by email at [email protected]

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