Don’t Use These Rapid COVID-19 Tests, FDA Warns
The US Food and Drug Administration recently issued a letter warning people not to use two different tests produced by Empowered Diagnostics.

On Jan. 28, the US Food and Drug Administration issued a letter warning people not to use two different tests produced by Empowered Diagnostics:
- The CovClear COVID-19 Rapid Antigen Test; and
- The ImmunoPass COVID-19 Neutralizing Antibody Rapid Test.
The FDA’s Empower Warning
The letter notes that both tests were distributed with labeling suggesting that they’ve been authorized by the FDA. But neither test has received FDA authorization, clearance, or approval for distribution or use in the US. The agency says that both tests pose high risk of false results. Meanwhile, Pompano Beach, Florida-based Empowered is recalling both tests, in what the FDA has classified as a Class 1 recall, the most serious type. The CovClear COVID-19 Rapid Antigen Test uses a nasal swab sample to detect SARS-CoV-2 antigens. The FDA’s recommendations:- Test users and caregivers: Talk to your health care provider if you were tested with the test and have concerns about your test results; and
- Health care providers and testing program organizers: If the antigen test was given less than two weeks ago and you suspect the result is inaccurate, consider retesting using an FDA authorized SARS-CoV-2 test; retesting isn’t necessary for tests done more than two weeks ago and where’s there’s no reason to suspect current SARS-CoV-2 infection.
- Test users and caregivers: Talk to your health care provider if you were tested with the test and have concerns about your test results; and
- Health care providers and testing program organizers: Consider retesting using an FDA authorized SARS-CoV-2 antibody test if you suspect a recent or prior SARS-CoV-2 infection.
Takeaway
Class 1 recalls of rapid COVID-19 tests have become a fairly regular occurrence in recent months. Although the Empowered tests involved in this case weren’t authorized by the FDA, many of the COVID-19 tests targeted for Class 1 recall have received Emergency Use Authorization, including Ellume’s COVID-19 Home Test (the first fully at-home SARS-CoV-2 testing kit to receive EUA for over-the-counter sale), Abbott’s Alinity m SARS-CoV-2 AMP Kit, and the Quidel Lyra PCR assay for COVID-19.This content is exclusive to National Lab Report subscribers
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