Risk of False Results with the Curative SARS-Cov-2 Test for COVID-19: FDA Safety Communication (01/04/2021)

Summary

Food and Drug Administration (FDA) bulletin sent 01/04/2021 02:05 PM EST carrying a safety communication titled Risk of False Results with the Curative SARS-Cov-2 Test for COVID-19. It says the FDA issued the communication to alert patients and health care providers of the risk of false results, particularly false negative results. It lists risks of a false negative result: 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, and other unintended adverse events. It says the communication provides recommendations for health care providers and for people who may have been tested, plus instructions for reporting problems.

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Risk of False Results with the Curative SARS-Cov-2 Test for COVID-19

U.S. Food and Drug Administration sent this bulletin at 01/04/2021 02:05 PM EST

If your email program has trouble displaying this email, view as a webpage . Risk of False Results with the Curative SARS-Cov-2 Test for COVID-19 - FDA Safety Communication Today, the U.S. Food and Drug Administration (FDA) issued a safety communication to alert patients and health care providers of the risk of false results, particularly false negative 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. Read the Communication Questions? If you have questions about this safety communication, contact the Division of Industry and Consumer Education (DICE) . | If your email program has trouble displaying this email, view as a webpage . Risk of False Results with the Curative SARS-Cov-2 Test for COVID-19 - FDA Safety Communication Today, the U.S. Food and Drug Administration (FDA) issued a safety communication to alert patients and health care providers of the risk of false results, particularly false negative 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. Read the Communication Questions? If you have questions about this safety communication, contact the Division of Industry and Consumer Education (DICE) . | If your email program has trouble displaying this email, view as a webpage . | Risk of False Results with the Curative SARS-Cov-2 Test for COVID-19 - FDA Safety Communication Today, the U.S. Food and Drug Administration (FDA) issued a safety communication to alert patients and health care providers of the risk of false results, particularly false negative 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. Read the Communication Questions? If you have questions about this safety communication, contact the Division of Industry and Consumer Education (DICE) . | Risk of False Results with the Curative SARS-Cov-2 Test for COVID-19 - FDA Safety Communication Today, the U.S. Food and Drug Administration (FDA) issued a safety communication to alert patients and health care providers of the risk of false results, particularly false negative 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. Read the Communication Questions? If you have questions about this safety communication, contact the Division of Industry and Consumer Education (DICE) .

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