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FDA Warns Empowered Diagnostics About Unauthorized COVID-19 Tests

NEW YORK – The US Food and Drug Administration has issued a warning letter to Empowered Diagnostics saying the firm made COVID-19 tests without the agency's approval, clearance, or authorization.

Last week, the agency released the warning letter it had sent to the Florida-based company Oct. 6 with demands that the company stop the sale and distribution of its CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test, review all labeling and promotional materials to remove any representations those products are safe and/or effective, and tell an agency COVID-19 task force within 48 hours what steps the firm has taken to address the violations. The agency also told the firm to, within 15 business days, describe steps the firm has taken to address quality system concerns, including corrective actions.

The letter also describes a series of previous violations identified during two inspections in February 2022. Inspectors found failures to meet test design requirements, identify and correct the root causes of nonconformances, establish adequate procedures to handle product complaints, and establish that components and finished products conform to specification, the letter states. It also indicates the firm responded in March that it is a small startup that was seeking Emergency Use Authorization to sell its products in the US, and it has made changes to correct deficiencies, which the agency would evaluate in follow-up inspections.

A year ago, the FDA announced a recall by Empowered Dx of the CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test after the agency found the company was marketing the tests without proper FDA authorization. The CovClear test received CE marking in 2021.