FDA Warnings re COVID-19 False Test Results

The FDA has issued two different warnings about false negative COVID-19 test results:

They have warned that the Curative SARS-Cov-2 test may provide false results that could threaten the safety of patients and staff, providing details and recommendations at https://www.fda.gov/medical-devices/safety-communications/risk-false-results-curative-sars-cov-2-test-covid-19-fda-safety-communication.

They have also warned that all SARS-CoV-2 molecular tests may provide false negatives on mutations of the virus, providing details and recommendations at https://www.fda.gov/news-events/press-announcements/fda-issues-alert-regarding-sars-cov-2-viral-mutation-health-care-providers-and-clinical-laboratory.

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