https://www.fda.gov/medical-devices/safety-communications/do-not-use-certain-sd-biosensor-pilot-covid-19-home-tests-fda-safety-communication

Do Not Use Certain SD Biosensor Pilot COVID-19 At-Home Tests: FDA Safety Communication

Date Issued: May 4, 2023

The U.S. Food and Drug Administration (FDA) is warning consumers and health care providers to stop using and throw out certain lots of recalled SD Biosensor, Inc. Pilot COVID-19 At-Home Tests, distributed by Roche Diagnostics. The FDA has significant concerns of bacterial contamination in the Pilot COVID-19 At-Home Test liquid solution, provided in the test kit. Direct contact with the contaminated liquid solution may pose safety concerns and the bacterial contamination could impact the performance of the test.

SD Biosensor, Inc. has initiated a recall for all impacted SD Biosensor Pilot COVID-19 At-Home Tests that were distributed by Roche Diagnostics to certain retailers in the United States. Approximately 500,000 tests were distributed to CVS Health, as well as about 16,000 tests to Amazon. The FDA is working with Roche Diagnostics to understand how many of those tests were sold to consumers.

Importantly, none of the impacted lots were distributed through COVID.gov/tests - Free at-home COVID-19 tests or as part of other federal testing programs. If you received your tests through the COVID.gov/tests distribution or as part of other federal testing programs, they are not subject to this safety communication or product recall.

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Dear RM Agents and Readers,

I know many people that bought tests and also those that received the free ones through the mail. And as I have been cynical about trusting any of it. That position seems to be the best over and over again. They are not attempting to help us, the bottom line is that they want us dead.

If you work from that position and understanding, it is easier to miss the bullets, so to speak.

Many Blessings,
CrystalRiver