FDA says ‘do not use’ three more at-home COVID-19 tests because of risk of ‘false results’ – PennLive

The U.S. Food and Drug Administration has issued warnings about three more at-home COVID-19 test kits that it has not authorized and may give false results.

The makers of all three tests also have issued recalls.

The FDA issued warnings about these tests yesterday:

Recalled COVID-19 at-home test kits

The FDA said consumers should not use the Celltrion DiaTrust COVID-19 Ag Rapid Test that has been recalled.

Those tests, the FDA said, have “not been authorized, cleared or approved by the FDA for distribution or use in the United States. The FDA is concerned about the risk of false results when using this unauthorized test.”

The FDA said ACON Laboratories has recalled all the Flowflex tests.

SD Biosensor has recalled its tests and Celltrion USA has recalled the DiaTrust tests.

In February, the FDA had issued warnings about the E25Bio COVID-19 Direct Antigen Rapid Test, the Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test for the same reasons.

Recalled COVID-19 at-home test kits

The FDA said consumers should not use the SD Biosensor Standard Q COVD-19 AG Home Test that has been recalled.

Leave a comment

Your email address will not be published. Required fields are marked *