Flowflex News & Product Updates

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

ACON Laboratories, Inc. has been continuously monitoring the emergence of SARS-CoV-2 variants. The Omicron variant of concern remains the dominant variant circulating globally, accounting for nearly all sequences submitted to GISAID. Among the Omicron variant, BA.2.12.1, BA.4, and BA.5 represent the highest proportion of circulating variants. Testing conducted by a third-party laboratory between May and July 2022 has indicated that the Flowflex™  COVID-19 Antigen Home Test does detect Omicron BA.2.12.1, BA.4, and BA.5 in patient specimens. ACON will continue to monitor the evolution of SARS-CoV-2 variants in circulation worldwide and evaluate the performance of our assays against future variants to maintain the high level of product performance our customers have come to rely upon. If you have questions, please contact

We at ACON Laboratories, Inc. have been continuously monitoring the emergence of COVID-19 variants. The Omicron variant (B.1.1.529) is currently the dominant variant circulating globally, accounting fornearly all sequences reported to GISAID. Omicron is made up of several sub-lineages, the most common ones are subvariant BA.1 and BA.2. An independent evaluation conducted by the National Institutes of Health’s (NIH) RADx program has indicated that the Flowflex™ COVID-19 Antigen Home Test does detect the Omicron subvariant BA.1 and BA.2 in live clinical samples. ACON will continue to monitor the evolution of COVID-19 variants in circulation worldwide and evaluate the performance of our assays against future variants to maintain the high level of product performance our customers have come to rely upon. Sincerely, Michael

SAN DIEGO, CA, January 9, 2022 – ACON Laboratories, Inc. (“ACON Laboratories”), the legal manufacturer of the “Flowflex™ COVID-19 Antigen Home Test” (FDA Emergency Use Authorization EUA210494), has identified the U.S. distribution of unauthorized, adulterated and misbranded counterfeit product having the trade name “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing).” ACON Laboratories is not importing the “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)” into the U.S. as it is only authorized for sale in Europe and other markets, under the CE mark. This press release serves as public announcement that this CE marked product is being recalled from the U.S. market. The “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)” cannot be legally imported, distributed, or used in the U.S. market as it has

ACON Laboratories, Inc. has been continuously monitoring the emergence of SARS-CoV-2 variants, including the Omicron variant. We are pleased to report that an independent evaluation conducted by the National Institutes of Health’s (NIH) RADx program has indicated that the Flowflex™ COVID-19 Antigen Home Test does detect the Omicron variant in live clinical samples. ACON will continue to monitor the evolution of COVID-19 variants in circulation worldwide and evaluate the performance of our assays against future variants to maintain the high level of product performance our customers have come to rely upon.

We at ACON Laboratories, Inc. have been continuously monitoring the emergence of SARS-CoV-2 variants and the Omicron variant is no exception. The Omicron variant is notable for the significant number of mutations in the Spike protein. Those mutations are not relevant to the Flowflex™ COVID-19 Antigen Home Test, which detects the SARS-CoV-2 Nucleocapsid protein. According to the GISAID analysis and the pairwise sequence alignment comparison of the Nucleocapsid protein from all of the tested variants (B.1.351, B.1.1.7, P.1, and Delta variant B.1.617.2), there is a high likelihood that the SARS-CoV-2 Omicron Variant (lineage B.1.1.529) is detectable by the Flowflex COVID-19 Antigen Home Test. We anticipate testing virus samples, once they become available to us, to further verify the performance of