FDA Issues Warning Letter for Unapproved COVID-19 Tests

The FDA has issued Florida-based test manufacturer Empowered Diagnostics a warning letter for distributing COVID-19 test kits without marketing approval, clearance or authorization.

The warning letter notes six issues: failing to establish and maintain design controls, not taking corrective actions after an audit, improperly handling customer complaints, inadequate quality control testing, packaging issues, and unsuitable document control procedures. 

The letter also stated that the firm does not have an approved application for either a premarket approval or an investigational device exemption, and that some units included inaccurate statements that the products were authorized for use under an Emergency Use Authorization. 

The FDA designated a recall of the company’s CovClear COVID-19 Rapid Antigen Tests and the ImmunoPass COVID-19 Neutralizing Antibody Rapid Tests as Class 1 in January because of the potential for serious injury or death due to inaccurate results.