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 Home Tests for sale in the United States. While these tests are branded with the ACON and Flowflex trademarks, they are not authentic Flowflex tests. ACON Laboratories has no way of confirming the accuracy or efficacy of these tests. ACON Laboratories understands that these tests are originating from China and are being imported illegally into the United States. ACON Laboratories has been made aware of the following companies who may be involved in the sale and/or distribution of these counterfeit Flowflex Antigen Home Tests:
- Canchi (China) Co. Ltd.
- Guangzhou Huiyao Import & Export Co. Ltd.
- Yiwu Trading
- Yuanhao Industry Ltd.
The above list is not exhaustive and ACON Laboratories’ investigation into the sources of counterfeit Flowflex COVID-19 Antigen Home Tests being sold into the United States remains ongoing. ACON Laboratories is working with FDA, CBP and other law enforcement agencies to identify and prevent the distribution of counterfeit Flowflex COVID-19 Antigen Home Tests into the United States. The above companies are not authorized sellers or distributors of ACON Laboratories and any statements by these companies’ suggesting an affiliation or association with ACON Laboratories or ACON Biotech are false. Further, the Flowflex COVID-19 Antigen Home Tests sold by these parties are not authentic and as such could pose a significant public health risk.
Resellers and customers are strongly encouraged to not do business with the above companies, and to closely scrutinize any communications or representations that third parties make about their affiliations or associations with ACON Laboratories. ACON Laboratories provides a list of authorized Flowflex distributors on its website, and resellers and customers should check this authorized distributor list before making any purchases. Distributors may also be verified by contacting info@www.aconlabs.com.
As described in a previous public notice, these counterfeit tests may be identified by several differences, including the absence of a Lot Number / Expiration Date / 2D-datamatrix label on the kit boxes, and a test cassette pouch labeled as “SARS-CoV-2 ANTIGEN RAPID TEST (SELF-TESTING)” with a Lot Number of COV2015122.
This is not a recall, as these counterfeits were not manufactured, imported, or distributed by ACON Laboratories. Resellers and consumers who encounter or possess counterfeit products should not use them and should destroy them. ACON Laboratories is unable to receive returns of any such counterfeit products you may possess.
If you have information regarding the distribution or sale of counterfeit Flowflex tests in the USA, including any sale of any Flowflex products packaged in blue boxes, please contact ACON Laboratories at info@www.aconlabs.com.
Individuals who encounter problems with the counterfeit device can report it to FDA as a voluntary adverse event report at: MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program. Alternatively, problems can be reported to FDA using either method below:
- Consumer Reporting Form FDA 3500B. Follow the instructions on the form to either fax or mail it in for submission. For help filling out the form, see MedWatchLearn.
- Call FDA at 1-800-FDA-1088 to report by telephone