FDA Medical Device Recalls (openFDA)
Abbott Diabetes Care, Inc.: Freestyle Navigator Continuous Glucose Monitor System, ABB NAV Dutch System Kit CE RE, AND ABB SYSTEM KIT, MMOL, EMEA AND ABB09 Dutch Kit New LCD. Abbot Item Number 70966-01, distributed by Abbott Lab. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.
- Recall number
- Z-1451-2010
- Recalling firm
- Abbott Diabetes Care, Inc.
- Product
- Freestyle Navigator Continuous Glucose Monitor System, ABB NAV Dutch System Kit CE RE, AND ABB SYSTEM KIT, MMOL, EMEA AND ABB09 Dutch Kit New LCD. Abbot Item Number 70966-01, distributed by Abbott Lab. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.
- Status
- Terminated
- Initiated
- 2009-04-14
- Posted
- 2010-04-30
- Terminated
- 2011-03-31
- Reason
- Potential failure or inaccurate readings--the device's plastic housing near the battery compartment may crack, and allow moisture to enter.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 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.
- Lot, serial or model codes
- Abbott Item # 70966-01 with multiple lot numbers, kits serial numbers, and Tx serial numbers. Lot numbers are these: 01M0028 or 01M0168 or 01K 2768 or 01K 2898 or 01K 3238 or 01K3328 or 01K3478 or 01M0028 or 01M0298 or or 01M1438 or 01M1638 or 01M2808. Kit Serial numbers beginning with BAAH 186 or BAAH 220 or BAAH 223 or BAAH 243 or BAAH 261 or BAAH 290 or BAAH 299 or BAAH 341and followed by a 5 digit number. TX Serial number beginning with AAAH 008 or AAAH 90 or AAAH 139 or AAAH 158 or AAAH 187 or AAAH195 or AAAH 212 or AAAH 221 or AAAH 228 or AAAH 239 or AAAH 268 or AAAH 296 or AAAH 354 and followed by a 5 digit number.
- 510(k) numbers
- not on file
- PMA numbers
- ["P050020"]
- Product code
- MDS
- Firm FEI
- 3002803444
- Firm city
- Alameda
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28