The warning applies to Lepu Medical Technology’s SARS-CoV-2 Antigen Rapid Test Kit and the Leccurate SARS-CoV-2 Antibody Rapid Test Kit.
Neither test has been authorized, cleared or approved by the FDA for use in the U.S. However, the FDA said the tests were still sold directly to consumers and distributed to pharmacies to be sold for at-home testing.
Healthcare providers should consider retesting patients with a different test who were previously tested with either of these products, the FDA said May 28.
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