FDA recalls unauthorized home coronavirus rapid tests due to wrong results

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The U.S. Food and Drug Administration (FDA) has warned consumers to stop using unauthorized COVID-19 rapid tests and antibody tests at home because of concerns that these kits may produce erroneous results. These kits produced by Lepu Medical Technology are distributed to pharmacies, sold to consumers for home testing, and provided through direct sales without FDA authorization.
According to the safety notice issued by the FDA, Lepu Medical Technology SARS-CoV-2 Antigen Rapid Test Kit and Leccurate SARS-CoV-2 Antibody Rapid Test Kit (colloidal gold immunochromatography) may cause false test results, “may cause People hurt, including serious illness and death.”
The antigen test is performed using a nasal swab, while the antibody test relies on serum, plasma or blood samples. The U.S. Food and Drug Administration said it has “serious concerns” about the performance of these two tests. It is recommended that healthcare providers who have used the antigen test in the past two weeks and suspected inaccurate results use a different kit to retest the patient. Those who recently used the antibody test and suspected that the results were wrong were also instructed to retest the patient with a different kit.
Since the beginning of COVID-19, the FDA has granted emergency use authorization for 380 testing and sample collection equipment.
Do not publish, broadcast, rewrite or redistribute this material. ©2021 FOX News Network Co., Ltd. all rights reserved. Quotes are displayed in real time or delayed for at least 15 minutes. Market data provided by Factset. Supported and implemented by FactSet Digital Solutions. Legal Notices. Mutual fund and ETF data is provided by Refinitiv Lipper.