The U.S. Food and Drug Administration (FDA) has issued a safety communication regarding certain SD Biosensor Pilot COVID-19 home test kits. The FDA has found that these test kits produce inaccurate results and may lead to serious health risks. Therefore, the agency is warning the public not to use these test kits and is urging healthcare providers to discontinue their use as well.
The affected test kits, manufactured by SD Biosensor, are intended for use by individuals at home and have been distributed widely across the United States. The FDA’s investigation revealed that the test kits have a high risk of producing false negative results, meaning that individuals who are infected with COVID-19 may receive a negative test result. This can lead to delayed or improper treatment and an increased risk of transmission to others.
The FDA is working closely with SD Biosensor to investigate the cause of the inaccurate test results and to determine the appropriate actions that should be taken to address this issue. The agency is also conducting its own assessment of the data and is working with other stakeholders to evaluate the potential impact of these test kits on public health.
In conclusion, individuals who have used or are planning to use the SD Biosensor Pilot COVID-19 home test kits should discontinue their use immediately and seek alternative testing options. Health care providers should also discontinue the use of these test kits and inform their patients of the potential risks associated with their use. The FDA is committed to protecting the public’s health and will continue to monitor this issue closely.