Class 2 Device Recall Remisol Advance Data Manager

• Date Initiated by Firm: August 15, 2019
• Create Date: March 03, 2020
• Recall Status: Terminated on June 03, 2021
• Recall Number: Z-1430-2020
• Recall Event ID: 83687
• Product Classification: Calculator/data processing module, for clinical use - Product Code JQP
• Product: Remisol Advance running on hardware with Windows XP, Windows 7, Windows Server 2003 and Windows Server 2008 operating systems
• Code Information: All serial numbers
• Recalling Firm/ Manufacturer: Normand-Info S.A.S.U.; 7 rue Frederic Degeorge; Arras CEDEX France
• Manufacturer Reason for Recall: A patch was released for a critical remote code execution vulnerability in remote desktop services. This vulnerability can be exploited remotely without authentication on certain operating systems. An attacker who successfully exploited this vulnerability could execute arbitrary code on the target system; then install programs; view, change, or delete data; or create new accounts with full user rights. If the vulnerability could be exploited locally, it would lock down the computer.
• FDA Determined Cause: Other
• Action: On 08/15/19, Urgent Medical Device Recall notices, dated 08/09/19, were mailed to customers informing them to follow the instructions in the notice to download the patch for their system(s). In addition, customers were asked to share this information with laboratory staff, to retain the notification as part of their laboratory Quality System documentation, and to complete and return the response form. If you are a centralized license holder, please provide the other affected laboratories of your organization or association with a copy of this letter. The latest information on cybersecurity can be found on the following website: https://www.beckmancoulter.com/en/about-beckman-coulter/product-security/product-security-updates. Customers with additional questions were encouraged to contact the firm via email at website: http://www.beckmancoulter.com. The following number was also provided: (800) 526-3821
• Quantity in Commerce: 6479
• Distribution: U.S.: NY, AZ, FL, NJ, MA, OH, CA, IL, NC, OK, IN, KY, OR, MI, WI, PA, UT, GA, VA, TX, NE, SD, IA, MN, MD, DE, SC, MT, WV, LA, MO, TN, NM, NV, HI, WA, WY, AL, AR, MS, RI, ID, ME, DC, ND, AK, CO, CT, KS, NH, VT
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.