1/29/2022- 4:04 p.m.
As COVID-19 tests become more prevalent, some, which have not been FDA approved have slipped through the cracks, and are now being recalled.
On Friday, the FDA issued a Class 1 recall on two COVID-19 tests. They say Class 1 is the most serious recall there is.
The FDA is urging the public to stop using the Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test.
Both tests were distributed with labeling indicating that they were authorized by the FDA but neither test has been authorized, cleared, or approved by the FDA for distribution or use in the United States.
The FDA is concerned about the potentially higher risk of false results when using unauthorized tests like the two that are now being recalled.
