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 appear to display an authentic Flowflex COVID-19 Antigen Home Test Lot number, these counterfeit test kits were not manufactured, imported, or distributed by ACON Laboratories. Counterfeit test kits displaying Lot number COV3090017 may be distinguished by examining the front of the kit box. On the counterfeit COV3090017 kit boxes, the sides of the illustrated tube do not extend into the teal. On authentic kit boxes, the sides of the illustrated tube extend into the teal and stop at the edge of the

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 appear to display an authentic Flowflex COVID-19 Antigen Home Test Lot number, these counterfeit test kits were not manufactured, imported, or distributed by ACON Laboratories. Counterfeit tests that display Lot number COV3090005 often produce invalid results (no Control line). The performance of these counterfeit tests has not been established and there is concern about the risk of inaccurate results when people use these unauthorized tests. Additionally, the 2D-datamatrix printed on the counterfeit test cassettes has been found to scan for invalid Lot

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 an authentic Flowflex COVID-19 Antigen Home Test Lot number, these counterfeit test kits were not manufactured, imported, or distributed by ACON Laboratories. These counterfeit test kits may be identified by mismatched Lot numbers on the test kit box label and test cassette pouch. These counterfeit test cassettes display a different Lot number on the test cassette pouch than the Lot number COV3060007 printed on the kit box label sticker on the outside of the test kit box. Additionally, these counterfeit test cassettes

SAN DIEGO, CA., July 29, 2024 – ACON Laboratories, Inc., a leading global medical device manufacturer for 25 years, announced today that its Flowflex® Plus COVID-19 and Flu A/B Home Test has been authorized for emergency use by the U.S. Food and Drug Administration. The new Flowflex Plus COVID-19 and Flu A/B Home Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens. This test is authorized for non-prescription home use with self-collected anterior nares nasal swab specimens from individuals aged 14 years or older, or with adult-collected anterior nasal swab specimens from individuals two (2) years or older. This test is only authorized for individuals with signs