Freestyle Navigator Continuous Glucose Monitor System, Clinical System Kit, Packaging. Abbott Item Number: PRT 03415-010

FDA device recall Z-1458-2010 · posted 2010-04-30 · Terminated

Recall details

Recalling firm

Abbott Diabetes Care, Inc.

Reason for recall

Potential failure or inaccurate readings--the device's plastic housing near the battery compartment may crack, and allow moisture to enter.

Action taken

Notification letters were issued to FreeStyle Navigator customers via certified mail and notification was posted on the Abbott Diabetes Care's Website. Customers were notified of the potential issue and actions to take: 1) if moisture is observed in the FreeStyle Navigator transmitter now or at any time, discontinue use of the transmitter and call Abbott Diabetes Care Customer Care at 1-800-418-6427 and 2) if a loss of connection is encountered or if your results are not reliable or are inconsistent with how you feel, consult your User's Guide for troubleshooting guidelines. If the issue is not resolved, call Abbott Diabetes Care Customer Care at 1-800-418-6421. For outside-of-US accounts, the firm's regional offices will distribute notices to identified customers in the appropriate language.

Root cause

Process control

Status

Terminated

Product code

MDS

Quantity affected

5,449 of total units

Distribution

Worldwide Distribution -- United States (OH, FL, NJ, CA, MS, MN, MA, and NY), France, Australia, the Netherlands, Sweden, the UK, Israel, Ireland and Germany.

Date initiated

2009-04-14

Date posted

2010-04-30

Date terminated

2011-03-31

Location

Alameda, CA