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FDA: Certain COVID-19 Serology/Antibody Tests Should Not Be Used

Letter to Clinical Laboratory Staff and Health Care Providers The U.S. Food and Drug Administration (FDA) recommends that clinical laboratories and health care providers stop using COVID-19 antibody tests that are listed on FDA’s “removed” test list, found on the FDA’s FAQs on Testing for SARS-CoV-2 webpage. The “removed” test list includes tests where significant […]

FDA: Filtering Facepiece Respirators from China May Not Provide Adequate Protection

Letter to Health Care Providers The U.S. Food and Drug Administration (FDA) is concerned that certain filtering facepiece respirators (respirators) from China may not provide consistent and adequate respiratory protection to health care personnel exposed to COVID-19 based on additional filtration performance testing conducted by the National Institute for Occupational Safety and Health (NIOSH) – […]