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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 CoPilotsee related information
Date Initiated by FirmAugust 30, 2005
Date PostedOctober 01, 2005
Recall Status1 Terminated 3 on May 16, 2006
Recall NumberZ-1594-05
Recall Event ID 33317
510(K)NumberK994433 
Product Classification Glucose Dehydrogenase, Glucose - Product Code LFR
ProductFreeStyle 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.
FEI Number 3002803444
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
ActionOn 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 CommerceProduct is downloadable software
DistributionSoftware, 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 CycleTPLC 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) Database510(K)s with Product Code = LFR
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