Accelerate Diagnostics, Inc.

Rosen Law Firm, a global investor rights law firm, continues to investigate potential securities claims on behalf of shareholders of Accelerate Diagnostics, Inc. (NASDAQ: AXDX) resulting from allegations that Accelerate Diagnostics may have issued materially misleading business information to the investing public.

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Details of investigation:

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.

公司名称: Accelerate Diagnostics, Inc.
股票代号: AXDX
集体诉讼期: N/A
法院: N/A


自 2013 年以来,罗森律师事务所每年都是代表投资者成功提起证券集体诉讼的前四大律所之一。仅 2019 年,本律所就为投资者追回 4.38 亿美元资金。


机构股东服务公司按 2017 年证券集体诉讼索赔数量,罗森律师事务所列为第一名。