Accelerate Diagnostics, Inc.
Investors that purchased the Company’s securities and have suffered a loss, please fill in transaction information below, or email to info@portnoylaw.com.
There is no cost or obligation associated with submitting your information. If you are a shareholder who suffered a loss, please submit your contact information and purchase information to participate in the putative class action.
We also encourage you to contact Lesley F. Portnoy of The Portnoy Law Firm, at 310.692.8883, to discuss your rights free of charge. You can also reach us through the firm’s website at www.portnoylaw.com, or by email at info@portnoylaw.com.
If you choose to take no action, you can remain an absent class member.
Joining the case through the Portnoy Law website enables investors to learn about their legal claims and take an active role in recovering their losses.
The Portnoy Law Firm represents investors around the world and specializes in securities class action lawsuits and shareholder rights litigation.
CONTACT:
Portnoy Law Firm
Lesley F. Portnoy, Esq.,
www.portnoylaw.com
Office: 310.692.8883
1800 Century Park East, Suite 600
Los Angeles, CA 90067
info@portnoylaw.com
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.
