CDRH New - February 22, 2022

If your email program has trouble displaying this email, view as a webpage. February 22, 2022 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on February 18, 2022. To view listings for other dates, see CDRH New - News and Updates. E25Bio Recalls COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA and May Give False Results BASE10 Genetics Recalls RNAstill MTM Specimen Collection Kits That Are Not Authorized, Cleared, or Approved by the FDA, May Give False Results, and Require Special Training for Safe Handling Do Not Use E25Bio COVID-19 Tests: FDA Safety Communication (Updated) About Manufacturer and User Facility Device Experience (MAUDE) (Updated) MDR Data Files (Updated) Medical Device Reporting (MDR): How to Report Medical Device Problems (Updated) Jobs at the Center for Devices and Radiological Health (CDRH) (Updated) Scientific Fellowships at CDRH STEM Career Opportunities at CDRH

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