WHY: 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.

SO WHAT: If you purchased Accelerate Diagnostics securities you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement. The Rosen Law Firm is preparing a class action seeking recovery of investor losses.

WHAT TO DO NEXT: To join the prospective class action, go to https://rosenlegal.com/submit-form/?case_id=9377 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action.

WHAT IS THIS ABOUT: 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.

WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources, or any meaningful peer recognition. Many of these firms do not actually litigate securities class actions. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs’ Bar. Many of the firm’s attorneys have been recognized by Lawdragon and Super Lawyers.

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