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 these counterfeit tests has not been established and there is concern about the risk of inaccurate results when people use these unauthorized tests.
Counterfeit Flowflex tests may also be identified by the color of the Control (C) line and Test (T) line after taking a test. If the color of the C line and/or T line is purple instead of red or pink, your test may be counterfeit. If that happens, please 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.