CAPE CORAL, Fla. The FDA wants you to stay away from a certain brand of COVID-19 test.
The U.S. Food and Drug Administration says antigen and antibody tests produced by LuSys Laboratories have a high chance of giving you false results.
“Neither trials have been authorized, authorized, or approved by the FDA for distribution or use in the United States,” the FDA said in a statement. warning message.
“In this case, what you have is a test that is found to give many false positives and many false negatives,” said Pam Seay, a legal expert at Florida Gulf Coast University.
The FDA went on to say that the tests “have not been fully established.”
Tests are manufactured by LuSys Laboratories but may have been sold under the names Luscient Diagnostics, Vivera Pharmaceuticals, or even EagleDx.
Is there a penalty for something like this?
“What’s going to happen is, they’re going to stop distributing and marketing, but they can still be on the shelf to buy,” says Seay.
The company has 15 days to close its marketing and distribution activities. However, a recall is unlikely.
“All they needed to do was tell people it wasn’t working,” Seay said.
This isn’t the first time LuSys Labs has taken the FDA hot seat. Back in 2015, FDA filings said the company recalled an Ebola virus antigen test kit in a situation similar to this one.
Seay recommends that if you’re buying a home test kit, read the fine print and make sure you’re getting an authentic test with guaranteed accurate results.
https://nbc-2.com/news/health/2022/01/12/fda-warns-to-stop-using-this-covid-19-test-cites-high-rate-of-false-results/ FDA warns against using this COVID-19 test, citing high false-result rate