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# False Results Warning on 2 Covid Tests
- URL: https://www.fdaweb.com/false-results-warning-on-2-covid-tests/
- Published: 2021-06-01T12:00:00.000Z
- Updated: 2026-09-14T17:01:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149436

FDA has issued a [safety communication](https://www.fda.gov/medical-devices/safety-communications/stop-using-lepu-medical-technology-sars-cov-2-antigen-and-leccurate-antibody-tests-fda-safety?ref=fdaweb.com) that warns against using Lepu Medical Technology SARS-CoV-2 Antigen Rapid Test Kit and the Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography). “The FDA has serious concerns about the performance of the SARS-CoV-2 Antigen Rapid Test Kit and the Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) and believes there is likely a high risk of false results when using these tests,” the alert says. Both tests have not been authorized, cleared or approved by FDA for distribution and use in the U.S. Additionally, Lepu Medical Technology is [recalling](https://www.fda.gov/medical-devices/medical-device-recalls/lepu-medical-technology-recalls-sars-cov-2-antigen-rapid-test-kit-and-leccurate-sars-cov-2-antibody?ref=fdaweb.com) the tests, which have been distributed to pharmacies to be sold for at-home testing by consumers as well as offered for sale directly to consumers.