FDA Issues Warning on 2 Recalled COVID-19 Tests

A medic collects a swab sample from an Israeli border guard at a COVID-19 drive-through testing site in a file photo. Ahmad Gharabli/AFP via Getty Images

The U.S. Food and Drug Administration (FDA) issued a warning about two COVID-19 tests made by Empowered Diagnostics because the tests aren’t approved by the FDA, even though the tests’ labels indicate that they are.

Empowered Diagnostics makes the CovClear COVID-19 Rapid Antigen and ImmunoPass COVID-19 Neutralizing Antibody Rapid tests.

Both tests have been recalled by Empowered Diagnostics, the FDA said in an announcement in late January. The recall is listed as a Class 1 recall, which the FDA’s website describes as the most serious type.

“The U.S. Food and Drug Administration (FDA) is warning people to stop using the Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test," the agency’s statement said. “These tests were distributed with labeling indicating they are 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 further said that individuals should not use either test due to the “potentially higher risk of false results when using unauthorized tests.”

People who used either test should talk to their health care provider if they have concerns about their test results, said the FDA.

“If the antigen test was given less than two weeks ago, consider retesting your patients using an FDA authorized SARS-CoV-2 diagnostic test if you suspect an inaccurate result,” the federal drug regulator said.

SARS-CoV-2 is another name for the CCP (Chinese Communist Party) virus, which causes COVID-19.

“False-positive results could lead test users to take fewer precautions to protect themselves from a future SARS-CoV-2 infection if the test result is interpreted to mean that they have had a previous SARS-CoV-2 infection,” according to the agency.

The CovClear COVID-19 Rapid Antigen Test nasal swab technology, while the ImmunoPass COVID-19 Neutralizing Antibody Rapid Test uses a fingerstick blood sample to determine whether one has COVID-19, the agency said.

The FDA also confirmed that it is working with Empowered Diagnostics to resolve issues around the recall and “will continue to keep the public informed of significant new information.”