Class 2 Device Recall ABL90 FLEX

• Date Initiated by Firm: July 10, 2019
• Date Posted: August 22, 2019
• Recall Status: Terminated on June 13, 2022
• Recall Number: Z-2320-2019
• Recall Event ID: 83312
• 510(K)Number: K092686
• Product Classification: Electrode, ion specific, potassium - Product Code CEM
• Product: ABL90 FLEX Analyzer REF 393090 UDI:05700693930909
• Code Information: All lots with the operating system versions - RXPE -UIM2743 v1.3XXXXXX or RXPE-UIM910 v1.3.XXXXXX
• Recalling Firm/ Manufacturer: Radiometer America Inc; 250 S Kraemer Blvd; Brea CA 92821-6232
• Manufacturer Reason for Recall: Software Security; The action is being initiated because of software security vulnerabilities with the firm's analyzer operating system, which may cause the device to shutdown or reboot resulting in delayed medical treatment.
• FDA Determined Cause: Software design
• Action: On (date), the firm will email a "Urgent Field Safety Notice" to all customers and will follow-up by mailing a copy of the "Urgent Field Safety Notice" to all customers via Federal Express with tracking and proof of delivery. The Urgent Field Safety Notice ask customers to do the following: 1. Check which version of the operating system (OS) is currently installed on your analyzer: o Logon to the analyzer o Touch Menu, Utilities, Temporary shutdown, and then Confirm o During the shutdown process the analyzer displays the version of OS installed " If the OS version is one of the following your analyzer is affected by the vulnerability: RXPE - UIM2743 v1.3.xxxxxx or RXPE-UIM910v1.3.xxxxxx 2. If your analyzer is found to be affected by the vulnerability the following options must be applied: Short term: If your analyzer is connected to a network and your IT department assesses that the Hospital Firewall and Network settings prevent a remote attacker from connecting to the analyzer to exploit the vulnerability, you may decide to keep the analyzer connected. Otherwise, we recommend disconnecting it until one of the long term countermeasures below has been implemented. Long term: Countermeasure 1: Contact your Radiometer representative to have the RXPE Security patch update installed on your analyzer. (Note: Microsoft does not support Windows XP anymore. However, Microsoft has extraordinarily released a patch for this particular vulnerability.) or Countermeasure 2: Contact your Radiometer representative to receive a quote for an upgrade to latest OS (Windows 7 embedded) from Radiometer, which is supported by Microsoft. 3.Please complete the Recall Response Form (last page of the customer advisory letter) and return it to your Radiometer representative. 4.Please Note: If you are not the end-user of the affected product, please ensure that this letter is distributed to the final end-users. If you have questions, please contact Radiometer
• Quantity in Commerce: 13,042 units
• Distribution: US: AB, AL, AR, BC, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TX, VA, VT, WA, WI, WV OUS: Canada, Netherland, China, Czech Republic, Denmark, Germany, Spain, France, Hugary, , indiat Japan, South Korea, United Kingdom, Australia, Poland, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, Finland, Brazil, and Mexico
• 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.

• 510(K) Database: 510(K)s with Product Code = CEM