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Healthline: At-Home COVID-19 test gets FDA warning: What to know
February 9, 2022
The Food and Drug Administration (FDA) announced recently that people should stop using the E25Bio rapid COVID-19 test. The agency warned that the test contains false labeling and instructions. The manufacturer says the E25Bio test uses a “novel technology” that is more accurate than a PCR test “without the need for equipment and at a fraction of the cost and time.”
However, according to the FDA, this test hasn’t been “authorized, cleared, or approved” by the FDA for distribution or use in the United States and may include false labeling claiming that the test is authorized by the FDA.
In a story published by Healthline, Carl Fichtenbaum, MD, of the Division of Infectious Diseases was the first expert source cited, that in an emergency, manufacturers might rush a product to market and don’t have to deal with full FDA approval.