Yahoo Web Search

Search results

1. www.cnet.com › health › medicalFDA Warns Against Some COVID Tests From Popular Brand Flowflex

   www.cnet.com › health › medical

   • Cached

   Mar 14, 2022 · While the Flowflex test that comes in a white box with the full name "Flowflex COVID-19 Antigen Home Test" is safe to use (it has an emergency use authorization from the FDA), there's a risk of ...

   • Author: Jessica Rendall

   • Occupation: Wellness Writer

2. www.fda.gov › medical-devices › safetyDo Not Use Certain ACON Flowflex COVID-19 Tests

   www.fda.gov › medical-devices › safety

   • Cached

   • Recommendations
   • Test Description
   • Risks of False Test Results
   • FDA Actions
   • Reporting Problems with Your Test
   • Questions?

   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 ACON Biotech Flowflex SARS-CoV-2 Anti...

   See full list on fda.gov

   The unauthorized ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) uses a nasal swab sample to detect proteins, called antigens, from SARS-CoV-2, the virus that causes COVID-19. Th...

   The ACON Laboratories Flowflex COVID-19 Antigen Home Test, authorized by the FDA on October 4, 2021, is not the subject of this Safety Communication and can continue to be used.

   See full list on fda.gov

   A false-negative antigen test resultmeans that the test says the person does not have COVID-19 but they actually do have COVID-19. A false-negative result may lead to delayed diagnosis or inappropr...

   A false-positive antigen test result means that the test says the person has COVID-19 but they are actually do not have COVID-19. A false-positive result may lead to a delay in both the correct dia...

   See full list on fda.gov

   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 Laboratories, Inc. to resolve this safety issue. ACON Laboratories, Inc. has initiated a recall for all unauthorized ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Tes...

   See full list on fda.gov

   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 personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

   See full list on fda.gov

   If you have questions about this Safety Communication, email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOVor call 800-638-2041 or 301-796-7100.

   See full list on fda.gov

3. www.fda.gov › media › 158005Flowflex COVID-19 Antigen Home Test - Shelf Life Extension

   www.fda.gov › media › 158005

   ACON Laboratories, Inc: Flowflex COVID-19 Antigen Home Test 21-month to 24-month self-life extension granted by the FDA on March 15, 2023. Lot Number. Tests with this printed expiration date. Now ...

4. www.fda.gov › media › 152698Flowflex COVID-19 Antigen Home Test – Instructions for Use

   www.fda.gov › media › 152698

   The Flowflex COVID-19 Antigen Home Test is a qualitative membrane based chromatographic immunoassay for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in human ...

5. www.kingcounty.gov › FlowFlex-FAQ-guideFrequently Asked Questions - King County

   www.kingcounty.gov › FlowFlex-FAQ-guide

   Flowflex COVID-19 Antigen Home Test. 1. What is the Flowflex COVID-19 Antigen Home Test? The 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. For use under an Emergency Use Authorization (EUA) only. 2.

6. www.aha.org › news › headlineNew COVID-19 home test authorized, another recalled

   www.aha.org › news › headline

   • Cached

   Oct 5, 2021 · The agency expects the ACON Laboratories Flowflex COVID-19 Home Test to double the nation’s rapid at-home testing capacity over the next several weeks. The manufacturer plans to produce more than 100 million tests per month by year’s end and 200 million per month by February 2022. In other news, Ellume on Friday recalled certain lots of its ...

7. www.nbcnewyork.com › news › coronavirusFlowflex Rapid Tests Recalled for Not Having U.S ...

   www.nbcnewyork.com › news › coronavirus

   • Cached

   Jan 14, 2022 · The Food and Drug Administration issued a recall late last month for “Flow flex SARS-CoV-2 Antigen Rapid Test (Self-Testing)," a product sold at an unknown number of pharmacies and distributed ...