FDA issued a safety communication to alert patients and healthcare providers of the risk of false covid-19 results, particularly false negative covid-19 results, with the Curative SARS-Cov-2 test. 

Risks to a patient of a false negative result include:

  • Delayed or lack of supportive treatment
  • Lack of monitoring of infected individuals and their household or other close contacts for symptoms, resulting in increased risk of spread of COVID-19 within the community
  • Other unintended adverse events.

This safety communication provides:

  • Important information regarding the use of the Curative SARS-Cov-2 Test.
  • Recommendations for health care providers whose patients may have been tested with the Curative SARS-Cov-2 Test.
  • Recommendations for people who may have been tested with the Curative SARS-Cov-2 Test.
  • Background on the issue and the FDA’s actions to address the issue.
  • Instructions for reporting problems with the Curative SARS-Cov-2 Test to the FDA.

For more information, read the FDA safety communication