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Double Whammy: Lepu Medical’s Class I COVID-19 Diagnostics Recall Followed By FDA Warning Letter

 
• By Shawn M. Schmitt

The US FDA sent the enforcement letter to China-based Lepu Medical Technologies roughly two months after the agency told health care providers to stop using COVID-19 tests made by the firm.

Vintage inscription made by old typewriter, warning

The US Food and Drug Administration has sent a warning letter to China-based Lepu Medical Technologies, roughly two months after the agency told health care providers and other stakeholders to stop using COVID-19 diagnostics made by the firm.

The warning letter, dated 29 July and posted online on 10 August, says Lepu Medical sold the Neutralization Antibody Test Kit, SARS-CoV-2 Antigen Rapid Test Kit, and Saliva Antigen...

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