Recall Z-1594-05 ยท LFR Glucose Dehydrogenase, Glucose
Abbott Diabetes Care, Inc.
FreeStyle CoPilot Web Based Data Management System, and FreeStyle CoPilot Health Management System,Versions 1 and 2. Web-based software system, no packaging.
| Date | Oct 1, 2005 (initiated Aug 30, 2005) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K994433 | CONNECT DATA MANAGEMENT SYSTEM Abbott Diabetes Care, Inc., May 5, 2000 |