Dr. Howard Smith Oncall

Unauthorized FlowFlex CoVid Test is Recalled

Informações:

Synopsis

  Vidcast:  https://youtu.be/0xkFOagge4k   The FDA and ACON Laboratories are warning consumers not to use the Flowflex SARS-CoV-2 Antigen Rapid Test packaged in a blue box.  This test is unauthorized for importing or use in the US.  The  product “Flowflex COVID-19 Antigen Home Test in a white box is FDA approved for use in the US and the recipient of an Emergency Use Authorization.  The Flowflex SARS-CoV-2 Antigen Rapid Test is approved in Europe while the US test is not.  So in summary, the  approved US test has the word “Home” in it and the European-approved test has the word “Rapid” in it.  The FDA states that the European test will not provide accurate results if used in the US.  If you obtained the FlowFlex test in the blue box, return it to the place of purchase.  For more information, contact ACON Laboratories Customer Support at 1-800-838-9502 or via email at flowflex_support@aconlabs.com.   https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/acon-laboratories-issues-recall-non-eua-au