The Division of Consumer Affairs is aware that healthcare practitioners are being contacted by certain laboratories and commercial pharmaceutical manufacturers advertising COVID-19 diagnostic and serology tests that are NOT approved or granted Emergency Use Authorizations (EUA) by the Food and Drug Administration (FDA).
Many of these communications are scams and the Division advises all healthcare professionals to be alert to this new type of fraud.
Healthcare professionals should not use diagnostic and serology tests that are not approved or have not been granted EUAs by the FDA, and should immediately stop using COVID-19 tests found on the FDA’s lists of tests for which EUA applications have been denied (the “removed” test lists).
The FDA recommends that healthcare providers,
Continuing to use tests found on the “removed” test lists could put patients’ health at risk and may subject healthcare professionals to disciplinary action by licensing boards. Therefore, be sure to frequently check the FDA’s “removed” test lists and the list of COVID-19 tests that the FDA has approved, above.
Healthcare providers can find additional information in the FDA’s Letter to Clinical Laboratory Staff and Health Care Providers and on the FBI’s alert, FBI warns of Potential Fraud in Antibody Testing for Covid-19.
If you have information about or are the victim of any of these scams, please submit a complaint to the FDA either by email at FDA-COVID-19-Fraudulent-Products@fda.hhs.gov or via the FDA’s reporting systems here (English) or here (Spanish). Please also copy the Division of Consumer Affairs by email at Dcaemail@example.com.
Thank you for the care you provide your patients and for your continued efforts to respond to the threat of COVID-19.
Paul R. Rodríguez
Division of Consumer Affairs New Jersey Department of Law and Public Safety