Class 2 Device Recall iSTAT DE

• Date Initiated by Firm: September 12, 2017
• Create Date: March 08, 2018
• Recall Status: Terminated on August 23, 2018
• Recall Number: Z-0926-2018
• Recall Event ID: 79150
• Product Classification: Calculator/data processing module, for clinical use - Product Code JQP
• Product: i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200 (UDI: 00054749001255)
• Code Information: All units that have been upgraded to software version 2.8
• FEI Number: 2245578
• Recalling Firm/ Manufacturer: Abbott Point Of Care Inc.; 400 College Rd E; Princeton NJ 08540-6607
• For Additional Information Contact: Larry Krasley; 609-454-9000
• Manufacturer Reason for Recall: Issues resulting from upgrade to software version 2.8: (1) Location, operator, stored patient lists will not update, and (2) Customized Reference Ranges, Action Ranges, and Custom Reportable Ranges are reset to factory default values. No erroneous results are generated as a result of this issue.
• FDA Determined Cause: Device Design
• Action: The following actions are recommended if you have already upgraded to version 2.8: 1. If you are using Location, Operator, or Patient lists. a. Delete the following files: i. C:\Istat32\LocInstData\LocInstData.txt ii. C:\Istat32\OpData\OpData.txt iii. C:\Istat32\PatData\PatData.txt iv. C:\Istat32\Log\iSTATDMI Errors.txt v. All files named C:\Istat32\Log\DeCustLogXX.txt; where XX is any two digits. b. Stop and restart the DECOMSRV service, which in turn restarts the DEDPSRV service. 2. If you are using customized Reference Ranges, Action Ranges, and Custom Reportable Ranges: a. Open DE Customization Workspace. b. For each profile, select preferences by clicking the button with the profile name. c. Navigate to the Results tab. d. Verify the Action and Custom Reportable Ranges. Click Edit to make changes. e. If changes are made, click the OK button to save. If you have not upgraded to i-STAT/DE version 2.8, make arrangements with your data management vendor to update to the newer version of i-STAT/DE at your earliest opportunity. DO NOT UPGRADE without coordinating with your data management vendor so that continuity of your i-STAT testing is not impacted. How should you verify what version of i-STAT/DE is installed on a computer? Using the Program and Features app in Windows is the best way to determine the version of i-STAT/DE installed on your system. To do so, follow these steps: 1. Open Control Panel and the Program and Features applet. 2. Locate the program named i-STAT/DE Version 2.8 in the list. 3. The version column will show 2.8 for the old version and 2.8.0.1 for the new version. If you determine the version 2.8.0.1 is not installed, make arrangements with your data management vendor to update to the latest validated version compatible with your data management system. Enclosed is an updated i-STAT/DE version 2.8, version qualifier, 2.8.0.1 CD-ROM and a Business Reply Card (BRC). Please complete and return the Business Reply c
• Quantity in Commerce: 894
• Distribution: Distributed in 48 States: AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, the District of Columbia, Australia, Italy, Sweden, and Canada.
• 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.