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U.S. Department of Health and Human Services

Class 2 Device Recall FreeStyle CoPilot

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  Class 2 Device Recall FreeStyle CoPilot see related information
Date Initiated by Firm August 30, 2005
Date Posted October 01, 2005
Recall Status1 Terminated 3 on May 16, 2006
Recall Number Z-1594-05
Recall Event ID 33317
510(K)Number K994433  
Product Classification Glucose Dehydrogenase, Glucose - Product Code LFR
Product FreeStyle CoPilot Web Based Data Management System, and FreeStyle CoPilot Health Management System,Versions 1 and 2. Web-based software system, no packaging.
Code Information N/A. Product is a software package.
Recalling Firm/
Manufacturer		 Abbott Diabetes Care, Inc.
1360 South Loop Road
Alameda CA 94502-7000
Manufacturer Reason
for Recall		 Downloadable software obtained from the firm's website displays user data (including but not limited to insulin levels and pump statistics data) in a matter that may be misinterpreted and result in mistreatment of therapy.
FDA Determined
Cause 2		 Other
Action On 8/30/05, the firm initiated the recall and its notification was via web postings and phone calls requesting discontinuation of the FreeStyle CoPilot from the website. A follow-up letter will be sent to registered users advising them of the issues and instructing them to not use CoPilot.
Quantity in Commerce Product is downloadable software
Distribution Software, distributed from website via clicking through an agrement to use only for informational purposes, and not as a substitute for professional medical advice treatment or diagnosis.
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 = LFR and Original Applicant = ABBOTT DIABETES CARE INC.
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