14th June 2021 Product update: rapidvirology staff writer
FDA Recalled COVID-19 Ag Test Never Meant for US Market Say Manufacturers
Lepu Medical has announced it is helping the FDA with the recall of its SARS-CoV-2 antigen and Leccurate Antibody test but insists its antigen test was never meant for the US market and had ceased to sell its antibody test after revoking its EUA application in June 2020.
In a statement issued to rapidvirology.com, Lepu Medical said that in March 2020, their Leccurate SARS-CoV-2 antibody rapid test kit had passed the US Notification 510 (K) list application process, and the test was allowed to be used in clinical institutions in the US. But, Lepu Medical then revoked their EUA application 3 months later and subsequently had their notification listing annulled.;
Regarding the antigen test, the statement reads: "Lepu has never tried to sell the product in the U.S market, while according to the customs data there have been 200,000 kits in the US market. They might have been shipped to other countries, transited via the US, or might have entered into the US market. At this point, we are probing and verifying the logistics of the products that went to distributors. Moreover, we are assisting FDA with the recall procedure based on the regulations as well."
The Class I recall issued by the FDA states the agency has serious concerns about the performance of both kits and believes there is likely a high risk of false results. However, when asked by rapidvirology if the recall was related to receiving reports on false results from consumers, the FDA simply stated that it was because the kits were not authorized.
Date Published: 14th June 2021
Note: This content has been edited by a rapidvirology.com staff writer for style and content.
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