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 numbers that do not match the Lot number COV3090005 printed on the test cassette pouch and on the kit box label sticker on the outside of the test kit box.
Individuals who have purchased or received Flowflex test kits displaying Lot number COV3090005 and believe that the tests may be counterfeit should save the test kit packaging and any unused tests and contact ACON’s customer support at 1-800-838-9502.
Authentic Flowflex COVID-19 Antigen Home Tests can be purchased from retail chain stores, major online resellers such as Amazon.com, or one of these authorized distributors.
Individuals who encounter counterfeit tests may also report it to the 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.
If you have any questions or concerns, please contact ACON’s customer support at 1-800-838-9502.