WebThe Flowflex COVID-19 Antigen Home Test is a rapid test for the detection of SARS-CoV-2 antigens in anterior nasal specimens. It is intended for self-testing use. ... The United States FDA has made this test available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by the Secretary of Health ... WebJan 26, 2024 · Recalled Test Kits. Recently, the FDA recalled 200,000 boxes of the Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), which is made by ACON Laboratories. The test does not have an emergency use authorization (EUA) from the FDA. The recalled test is in a blue box while the approved version is in a white box.

FlowFlex Covid-19 Rapid Home Test - Diabetic Outlet

Webflowflex® covid-19 antigen home test kits ACON Laboratories, Inc., has become aware that counterfeit versions of its FDA-authorized Flowflex® COVID-19 Antigen Home Tests in … If you have an ACON Flowflex COVID-19 test, compare the packaging to the image above. Do not use the ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) in the dark blue packaging, as shown above. 1. Test users and caregivers:Talk to your health care provider if you think you were tested with the … See more The FDA regularly monitors the marketing of unauthorized, unapproved, or uncleared tests, including reports of problems with test performance or results. The FDA is working with ACON … See more If you think you had a problem with a SARS-CoV-2 test, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form. Health care … See more small business bank of america phone number

Flowflex USA: Get Your Rapid Antigen Tests Here

WebMar 16, 2024 · The recalled Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) comes in a dark blue box has a CE mark on the bottom of the front label. The recalled one will also say on the side panel that it ... WebThe “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)” cannot be legally imported, distributed, or used in the U.S. market as it has not been approved, cleared, or … Webtest made available under an EUA, when appropriate and available. FDA has issued EUAs for ... Flowflex COVID-19 Antigen Home Test - Healthcare Provider Fact Sheet Author: FDA CDRH small business bank of america online