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# Class 1 Recall of E25Bio Covid-19 Test
- URL: https://www.fdaweb.com/class-1-recall-of-e25bio-covid-19-test/
- Published: 2022-02-22T12:00:00.000Z
- Updated: 2026-09-14T17:33:40.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151213

FDA has classified as Class 1 a recall of the E25Bio Covid-19 Direct Antigen Rapid Test. “This test has not been authorized, cleared, or approved by the FDA for distribution or use in the United States, and it may include false labeling representing that the test is authorized by the FDA,” an [agency notice](https://www.fda.gov/medical-devices/medical-device-recalls/e25bio-recalls-covid-19-direct-antigen-rapid-tests-are-not-authorized-cleared-or-approved-fda-and?ref=fdaweb.com) says. FDA is concerned about the risk of false results because E25Bio has not provided the agency with adequate data demonstrating its performance is accurate.