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# Warning on ACON Biotech Covid Tests
- URL: https://www.fdaweb.com/warning-on-acon-biotech-covid-tests/
- Published: 2022-03-11T12:00:00.000Z
- Updated: 2026-09-14T17:36:12.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151349

FDA has issued a [warning](https://www.fda.gov/medical-devices/safety-communications/do-not-use-certain-acon-flowflex-covid-19-tests-fda-safety-communication?ref=fdaweb.com) against using ACON Biotech Covid-19 tests. The agency says the China-made tests are labeled “Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)” and packaged in a dark blue box. This test has not been authorized, cleared, or approved for distribution or use in the U.S., FDA says. The agency is concerned about the risk of false results when using the unauthorized tests.