US FDA recalls & asked consumers to discard SD Biosensor’s covid at home test

US FDA home kits


As a direct consequence of the COVID-19 epidemic, major adjustments have been made to our typical everyday activities. One of these shifts is the rise in popularity of testing kits that can be done at home. People are now able to do straightforward COVID-19 testing in the comfort of their own homes with the assistance of kits that have been given US FDA approval. Recent events have shown that not all at home testing kits are created equal, despite the fact that many manufacturers claim otherwise.

What prompted the product recall?

Consumers and healthcare professionals have been advised by the US Food and Drug Administration (FDA) to immediately cease using and dispose of certain batches of recalled SD biosensors and pilot COVID-19 at-home tests sold by Roche Diagnostics. The Food and Drug Administration (FDA) has serious concerns about the possibility of bacterial contamination in the pilot COVID-19 at-home test liquid solution that is sold with the test kit. It is possible that coming into contact with the liquid solution could raise certain safety concerns and that bacterial contamination will have an impact on the outcome of the test.

The United States Food and Drug Administration (FDA) noted in a statement that 16,000 tests were sent to Amazon, while over 500,000 tests were provided to CVS Health. According to the statement, the United States Food and Drug Administration (FDA) and Roche Diagnostics are working together to determine how many of those tests were sold to individual customers.

In the United States, the reliability of infection data began to diminish about the same time that more people started using at-home, rapid COVID tests rather than laboratory procedures like PCR. The vast majority of patients do not share their findings.

There are still hundreds of new cases of the coronavirus in the United States each week. However, after May 11, when the public health emergency will no longer be in effect, labs all throughout the country will no longer be required to report the findings of their COVID tests to the Centers for Disease Control and Prevention. Because of this, it is likely that the CDC’s COVID Data Tracker will, at some point in the future, cease posting its weekly information on infection, transmission, and the community level.

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