Flowflex News & Product Updates

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

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. Among the new Omicron variants, BA.2.86 and JN.1 are currently the fastest-growing variants in the United States. Based on the study results from testing live clinical samples or virus samples of variants, the Flowflex® COVID-19 Antigen Home Test can reliably detect the Omicron B.1.1.529, BA.1, BA.2, BA.2.12.1, BA.2.3, BA.2.75.5, XBB, BA.4, BA.4.6, BA.5, BA.5.5, BQ.1, BQ.1.1, BQ.1.3, BQ.1.16, BF.5 and BF.7 variants with various nucleocapsid protein mutations, including many defining mutations for the Omicron variants. Therefore, our test has demonstrated adequate sensitivity against

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 (OTC) rapid antigen test for SARS-CoV-2, the virus which causes COVID-19. The 510(k) version of the Flowflex COVID-19 Antigen Home Test will also be produced domestically, in ACON Laboratories’ new 97,000 square foot San Diego manufacturing facility. The 510(k) cleared Flowflex COVID-19 Antigen Home Test is indicated for use only by symptomatic individuals within the first six days after symptom onset. An initial negative result must be followed by retesting between 48 and 72 hours after the

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 concern “COV2110012” is not an authentic lot number of the Flowflex® COVID-19 Home Test manufactured by ACON Laboratories. This is not a manufacturer recall, as these are counterfeit tests that were not manufactured, imported, or distributed by ACON. Consumers should take precautions to avoid purchasing or using Flowflex tests marked with Lot# COV2110012. These counterfeit tests have not been authorized, cleared, or approved by the FDA for distribution or use in the United States. The performance of

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, among the new Omicron variants, XBB.1.9.1.1.5.1 (FL.1.5.1) and XBB.1.9.2.5 (EG.5) represent the highest portion of new COVID-19 infections nationwide. We have clinically verified that the Flowflex® COVID-19 Antigen Home Test can reliably detect the Omicron BA.1, BA.2, BA.4, BA.5 and BQ.1.1 variants with various nucleocapsid protein mutations, including many defining mutations for the Omicron variants. Therefore, our test has demonstrated broad sensitivity against a wide range of Omicron subvariants. While we have not tested the live clinical Omicron XBB subvariant samples, the GISAID

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 COVID-19 Antigen Home Test shelf-life from 12 months to 24 months, when stored at 36-86°F (2-30°C), has been granted.

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 nearly all sequences submitted to GISAID. Among the new Omicron variants, BQ.1.1, BQ.1, XBB.1.5, XBB, and BF.7 represent the highest proportion of circulating variants in the United States. An independent evaluation conducted by the National Institutes of Health’s (NIH) RADx program has indicated that the Flowflex COVID-19 Antigen Home Test detects the variants BQ.1.1 and BA.2 in live clinical samples. Another evaluation conducted by a third-party laboratory has shown that the Flowflex COVID-19 Antigen Home Test detects live variants BA.4 and BA.5. According

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 unauthorized distributors. These counterfeit tests have not been authorized, cleared, or approved by the FDA for distribution or use in the United States, but their packaging and components may very closely resemble authentic FDA-authorized Flowflex tests. Consumers should take precautions to avoid purchasing Flowflex in the 1 Test/ kit box configuration marked as Lot# COV2010030 and COV2030016, that was not distributed through an authorized distributor. ACON is currently not aware of any counterfeit tests in the 2 Test/ kit box and