News
PUBLIC NOTICE OF COUNTERFEIT FLOWFLEX® COVID-19 TEST KITS
ACON Laboratories, Inc. has become aware of counterfeit Flowflex COVID-19 Antigen Home Test kits displaying Lot number COV3090017 which are being illegally sold in the United States and Puerto Rico by unauthorized distributors. Although these counterfeit test kits...
PUBLIC NOTICE OF COUNTERFEIT FLOWFLEX® COVID-19 TEST KITS
ACON Laboratories, Inc. has become aware of counterfeit Flowflex COVID-19 Antigen Home Test kits displaying Lot number COV3060007 which are being illegally sold in the United States by unauthorized distributors. Although these counterfeit test kits appear to display...
PUBLIC NOTICE OF COUNTERFEIT FLOWFLEX® COVID-19 TEST KITS
ACON Laboratories, Inc. has become aware of counterfeit Flowflex COVID-19 Antigen Home Test kits displaying Lot number COV3090005 which are being illegally sold in the United States and Puerto Rico by unauthorized distributors. Although these counterfeit test kits...
STATEMENT ON THE OMICRON BA.2.86 and JN.1 VARIANTS
ACON Laboratories, Inc. has been continuously monitoring the emergence of SARS-CoV-2 variants. According to the Centers for Disease Control and Prevention (CDC) COVID Data Tracker, the Omicron variant remains the dominant variant circulating in the United States....
ACON Receives FDA 510(k) Clearance for Flowflex® COVID-19 Test; Will be Manufactured in San Diego
SAN DIEGO, CA, November 9, 2023 – ACON Laboratories, Inc. is proud to announce that the U.S. Food & Drug Administration (FDA) has granted 510(k) marketing clearance for the Flowflex® COVID-19 Antigen Home Test. This is the first FDA 510(k) for an over-the-counter...
Recall Issued by the Philadelphia Department of Public Health for Counterfeit Flowflex COVID-19 Tests
ACON Laboratories, Inc. is aware of the announcement by the Philadelphia Department of Public Health of a recall of certain at-home COVID-19 tests on September 9, 2023, and actively working with them and the FDA to conduct further investigation. The Lot number of...
STATEMENT ON THE OMICRON EG.5 and FL.1.5.1 VARIANT
ACON Laboratories, Inc. has been continuously monitoring the emergence of SARS-CoV-2 variants. According to the Centers for Disease Control and Prevention (CDC) COVID Data Tracker, the Omicron variant remains the dominant variant circulating in the United States,...
Flowflex COVID-19 Antigen Home Test New Shelf-life Extension
Since the launch of its Flowflex COVID-19 Antigen Home Test, ACON Laboratories, Inc. has continued testing for product stability to extend the shelf-life. These results have been shared with the FDA. We are pleased to announce that the request to extend the Flowflex...
STATEMENT ON THE NEW OMICRON VARIANTS (BQ.1.1, BQ.1, XBB.1.5, XBB, and BF.7)
ACON Laboratories, Inc. has been continuously monitoring the emergence of SARS-CoV-2 variants to ensure that the Flowflex® COVID-19 Antigen Home Test can detect them. The Omicron variant of concern remains the dominant variant circulating globally, accounting for...
PUBLIC NOTICE OF COUNTERFEIT FLOWFLEX™ COVID-19 TEST KITS
ACON Laboratories, Inc., has become aware that counterfeit versions of its FDA-authorized Flowflex® COVID-19 Antigen Home Tests in the 1 Test/ kit box configuration marked as Lot# COV2010030 and COV2030016 are being illegally distributed in the United States through...