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Do Not Use Skippack Medical Lab SARS-CoV-2 Antigen Test
May 10 – This test is not authorized, cleared, or approved by the FDA for distribution or use in the United States.
Learn more about devices such as diagnostic tests, ventilators, and personal protective equipment (PPE)—including surgical masks, face shields, respirators, gowns, and gloves.
Learn MoreMay 10 – This test is not authorized, cleared, or approved by the FDA for distribution or use in the United States.
Apr 29 - These counterfeit tests should not be used or distributed.
Mar 18 - FDA issued a safety communication to use and store at-home COVID-19 tests properly to avoid potential harm.
Jun 6-10 – Register for this free conference on topics including 510(k)s, inspections, and regulatory responsibilities.
May 2 - Find answers to frequently asked questions on Philips Respironics ventilators, BiPAP, and CPAP machines recall.
The FDA issued a safety communication to warn consumers that use of the Max-Lux Safe-T-Lite UV WAND may expose the user or person nearby to unsafe levels of ultraviolet-C (UV-C) radiation and may cause injury to the skin, eyes, or both after a few seconds of use.
Information and news on device recalls, other safety issues, approvals, and other device and radiation-emitting product topics.