News
Flowflex® Plus COVID-19 and Flu A/B Home Test Receives FDA EUA
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....
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...
ACON Laboratories, Inc. Announces the Launch of On Call® MultiPro
HbA1c, ACR and CRP Now Available in Europe and Latin America San Diego — August 30, 2023, ACON Laboratories, Inc. announced availability of the On Call® MultiPro System for point-of-care testing in physician offices, clinics and hospitals. The system features...
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 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,...