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PUBLIC NOTICE OF COUNTERFEIT
FLOWFLEX® COVID-19 ANTIGEN HOME 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...
STATEMENT ON THE OMICRON BA.2.12.1, BA.4, and BA.5 VARIANTS
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,...
Known Distributors of Counterfeit Flowflex™ Tests
ACON Laboratories, Inc. (“ACON Laboratories”), the legal manufacturer of the “Flowflex™ COVID-19 Antigen Home Test” (FDA Emergency Use Authorization EUA210494), has identified the distribution of unauthorized, adulterated and misbranded counterfeit Flowflex Antigen...
PUBLIC NOTICE OF COUNTERFEIT FLOWFLEX™ COVID-19 TEST KITS
ACON Laboratories, Inc., of San Diego, California, has become aware that counterfeit versions of its FDA-authorized Flowflex™ COVID-19 Antigen Home Tests are being illegally imported and sold in the United States through unauthorized distributors and resellers who...
STATEMENT ON THE OMICRON BA.2 VARIANT
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...
ACON Laboratories Issues a Recall of non-EUA Authorized “Flowflex™ SARS-CoV-2 Antigen Rapid Test (Self-Testing)” Tests From the U.S. Market
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...
UPDATED STATEMENT ON THE OMICRON VARIANT
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...
Trade Shows 2022
AACC American Association for Clinical Chemistry July 26th – July 28th 2022 McCormick Convention Center Chicago, Illinois Booth 667 NACDS TSE National Association of Trade Drug Stores August 27th - August 29th 2022 Boston Convention Center Boston, Massachusetts Booth...
STATEMENT ON THE OMICRON VARIANT
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...
Flowflex™ COVID-19 Home Test Receives FDA EUA
SAN DIEGO, CA., October 4, 2021 – ACON Laboratories, Inc., a leading global medical device manufacturer for 25 years, announced today that its Flowflex™ COVID-19 Antigen Home Test has been authorized for emergency use by the U.S. Food and Drug Administration.The...