Events

Recall of iSTAT DE

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Point Of Care Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79150
  • Event Risk Class
    Class 2
  • Event Number
    Z-0926-2018
  • Event Initiated Date
    2017-09-12
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161446
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Calculator/data processing module, for clinical use - Product Code JQP
  • Reason
    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.
  • 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

Device

iSTAT DE
  • Model / Serial
    All units that have been upgraded to software version 2.8
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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.
  • Product Description
    i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200 (UDI: 00054749001255)
  • Manufacturer
    Abbott Point Of Care Inc.

Manufacturer

Abbott Point Of Care Inc.
  • Manufacturer Address
    Abbott Point Of Care Inc., 400 College Rd E, Princeton NJ 08540-6607
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA