Z-1594-05

FreeStyle CoPilot Web Based Data Management System, and FreeStyle CoPilot Health Management System,Versions 1...

Name: Z-1594-05 FreeStyle CoPilot Web Based Data Management System, and FreeStyle CoPilot Health Management System,Versions 1...
Creator: Abbott Diabetes Care, Inc.
Published: 2005-08-30
License: https://open.fda.gov/license/

Abbott Medical / initiated 2005-08-30 / Terminated / root cause: software

FDA source

Abbott Diabetes Care, Inc. began a recall of FreeStyle CoPilot Web Based Data Management System, and FreeStyle CoPilot Health Management System,Versions 1 and 2. Web-based software system, no packaging on 2005-08-30. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1594-05
Status: Terminated
Initiated: 2005-08-30
Posted: 2005-10-01
Terminated: 2006-05-16
Recalling firm: Abbott Medical
Product: FreeStyle CoPilot Web Based Data Management System, and FreeStyle CoPilot Health Management System,Versions 1 and 2. Web-based software system, no packaging.
Product code: LFR Glucose Dehydrogenase, Glucose
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.
Root cause tag: software
FDA 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 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.
Product codes and lots: N/A. Product is a software package.

Product code LFR

K994433Class IIConnect Data Management SystemAbbott Diabetes Care, Inc. / cleared 2000-05-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)