FDA Issues Warning About Unauthorized Covid-19 At-Home Tests

The U.S. Food and Drug Administration (FDA) is warning people not to use the SD Biosensor Inc. STANDARD Q COVID-19 Ag Home Test. The test is not authorized, cleared, or approved by the FDA for distribution or use in the United States. The FDA is concerned about the risk of false results when using this unauthorized test. This unauthorized test may be packaged in a white and magenta box.

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May 27, 2020 #covidscams video: Fake N95 masks threaten our first responders and healthcare workers

Image of Shabbir Safdar on video

The era of COVID-19 has been marked by shortages of medical equipment–hand sanitizer, test kits, gloves and, most of all, protective masks for healthcare workers and first responders. On May 13th, the Associated Press (AP) published a disheartening investigative piece–one in a series about the challenges of a worldwide medical supply chain–that shows just how difficult it is to establish that important medical supplies are safe and effective over the whole course of the purchasing process.

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Policy Resolution on Counterfeit Device Destruction, May 8, 2020

The following policy resolution was passed unanimously at the May 8, 2020 Advisory Board meeting: The Partnership for Safe Medicines believes that counterfeit medical devices are dangerous to American patients and that the U.S. Food and Drug Administration (FDA) should have the unequivocal power to seize and destroy these dangerous products whether they are found…

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