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COVID-19 Testing Scams Alert: Beware of Non-FDA Approved COVID-19 Test Scams

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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,

  • Verify here prior to use whether any tests provided are approved by, or have been granted EUAs from, the FDA;
  • Monitor and review the FDA’s “removed” test lists;
  • Evaluate, given the patient’s clinical presentation and medical history, whether prior test results generated using these tests may have been incorrect, and whether the patient should be retested using an FDA-approved or FDA-authorized test;
  • Remove from stock any remaining tests that are not FDA approved or authorized, including those listed on the FDA’s “removed” test lists; and
  • Report any issues with COVID-19 tests to the FDA.

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 Dca-covid19@dca.njoag.gov.

Thank you for the care you provide your patients and for your continued efforts to respond to the threat of COVID-19.

Sincerely,

Paul R. Rodríguez

Acting Director

Division of Consumer Affairs New Jersey Department of Law and Public Safety

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