After the market closed on October 21, 2022, Accelerate Diagnostics, Inc. disclosed receiving a request from the U.S. Food and Drug Administration for the company to immediately discontinue marketing and distribution of its Accelerate Arc system and related BC Kit for a particular diagnostic use.
Previously, Accelerate Diagnostics had been marketing the Accelerate Arc products as Class I devices, exempting them from 510(k) clearance requirements. Recently, the FDA informed the company that marketing the products in the U.S. requires 510(k) clearance.
Shares of Accelerate Diagnostics, Inc. stock dropped approximately 9% in premarket trading and were down more than 40% in intraday trading on October 24, 2022.
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