Class 2 Device Recall ABL 80 COOX SYSTEM

• Date Initiated by Firm: February 20, 2009
• Date Posted: November 10, 2009
• Recall Status: Terminated on July 16, 2012
• Recall Number: Z-0150-2010
• Recall Event ID: 52791
• 510(K)Number: K080370
• Product Classification: Analyzer - Product Code CHL
• Product: ABL 80 CO-OX SYSTEM, software versions 1.30 and 1.31; ; Additional Product Codes: CEM, CGA, CGZ, GHS, GKR, GLY, JFP, JGS, JIX, JJY, JPI; ; The ABL 80 CO-OX SYSTEM is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL 80 CO-OX SYSTEM is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.
• Code Information: Model Number: 393-841 all serial numbers are affected.
• Recalling Firm/ Manufacturer: Sendx Medical Inc; 1945 Palomar Oaks Way; Carlsbad CA 92009-1307
• For Additional Information Contact: 760-603-6300
• Manufacturer Reason for Recall: Inverness have recently become aware of a potential error contained in V1.30 and V1.31 software for the ABL 80 CO-OX platform. The error can occur if the analyzer is set to automatically upload patient records to Radiance or an HIS/LIS system. This can result in the reporting of incorrect results for one or more CO-OX derived parameters. Incorrect results can be displayed on the screen and the
• FDA Determined Cause: Other
• Action: Radiometer sent out a letter to consignees informing them of public reason for recall, and telling them that they have provided a copy of the upgrade software and instructions to correct this potential problem immediately. Software upgrade instructions were included with the recall letter. Consignees were informed that if they preferred that their local service representative perform the upgrade, to follow the Instructions for disabling auto upload of patients records. SOFTWARE UPGRADE INSTRUCTIONS: The upgrade software must be installed via the Software Upgrade option under Menu>Utilities>Software Upgrade. It is not a "boo table" CD. ~The Upgrade process will take approximately 10 minutes. The analyzer should be allowed to complete the entire process without user interaction. Do not attempt to turn the analyzer on or off manually at any time during the process. ~The upgrade process will include the following general steps: 1. Automatic power down and reboot of the analyzer 2. File transfer process which includes a variety of progress bars to communicate the status 3. Automatic power down and reboot of the analyzer a second time 4. A dialog box on the main menu screen that states, "ABL80 FLEX software has been upgraded to version 1.32." This signifies a successful upgrade process. ~If a solution pack and a sensor cassette are already installed on the analyzer, their installation status will not be affected by the software upgrade. ~All stored data will be retained in all logs They were also asked to complete and return the attached fax form, with their signature, to 1-800-736-0601. If their were any questions regarding the letter, or upgrade, to contact Techline at 1-800-736-0600 opt.
• Quantity in Commerce: 317
• Distribution: Domestically and Worldwide: Germany, France, Spain, United Kingdom, Poland, Austria, Italy, Tokyo, Australia, and Denmark Domestically to OH
• 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 = CHL and Original Applicant = SENDX MEDICAL, INC.