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Posted June 4, 2021

COVID Antibody and Antigen Tests That May Give False Results Recalled

On May 28, 2021, the FDA warned consumers not to use the Lepu Medical Technology SARS-CoV-2 Antigen Rapid Test Kit and the Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) due to a "high risk of false results when using these tests." 

These tests have been distributed to pharmacies to be sold for at-home testing by consumers as well as offered for sale directly to consumers in the U.S. despite not being authorized, cleared or approved by FDA for distribution or use.

(For information about FDA authorized COVID tests, including at-home tests, see ConsumerLab's article about Finding the Best COVID Tests).

Lepu Medical Technology issued a recall of these tests on April 26, 2021. The recall includes all lots of the tests, including at least at least 8,419,545 antibody tests and 205,175 antigen tests distributed from approximately March 20, 2020 to the present.

It is a Class I recall, the most serious type of recall, and the FDA has warned that "Use of these devices may cause serious injuries or death." There have been no reports of injuries or death from use of these tests to date.  

The FDA advises people who have used these tests and have concerns about their test results to consult with their healthcare provider.

For more information, use the link below.

Stop Using Lepu Medical Technology SARS-CoV-2 Antigen and Leccurate Antibody Tests: FDA Safety Communication

See related recalls and warnings:

FDA Warns 5 Sellers of Unapproved COVID-19 Tests

FDA Warns Consumers about Fraudulent Tests, Vaccines, and Treatments for COVID-19

FDA Warns Seller of Unapproved "COVID-19 test package"