Accelerate Diagnostics, Inc.
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On October 21, 2022, after market hours, Accelerate Diagnostics’ filed a current report with the SEC on Form 8-K which announced that, pursuant to discussions with the U.S. Food and Drug Administration (“FDA”), the Company would, among other things: “(i) discontinu[e] the U.S. marketing and distribution of [its Accelerate Arc system and related BC Kit (collectively, the “Accelerate Arc Products”)] for positive blood culture processing and subsequent identification by mass spectrometry for diagnostic use; (ii) remov[e] and/or correct all U.S. promotional information within the Company’s control (e.g., website, labeling, social media, sales associate information, or other promotional material) regarding the diagnostic use of the Accelerate Arc Products as Class I devices or as devices intended as positive blood culture processing devices for subsequent identification of microorganisms by mass spectrometry; and (iii) revis[e]/remov[e] the Company’s registration and listing of the Accelerate Arc Products as Class I devices.”
Previously, “[t]he Company had been listing the Accelerate Arc Products as a Class I device exempt from 510(k) clearance requirements[,]” but “the FDA has clarified that the Company must obtain a 510(k) clearance in order to continue marketing and distributing the Accelerate Arc Products in the United States.”
On this news, Accelerate Diagnostics’ stock fell sharply during pre-market trading and continued to fall sharply during intraday trading on October 24, 2022, the next trading day.