FDA Medical Device Recalls (openFDA)
Abbott Diabetes Care, Inc.: FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips. Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502 USA The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the FreeStyle InsuLinx Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip.
- Recall number
- Z-1245-2013
- Recalling firm
- Abbott Diabetes Care, Inc.
- Product
- FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips. Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502 USA The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the FreeStyle InsuLinx Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip.
- Status
- Terminated
- Initiated
- 2013-04-15
- Posted
- 2013-05-09
- Terminated
- 2015-08-03
- Reason
- AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading.
- Root cause
- Software design
- Action
- Abbott Diabetes Care sent an Urgent Product Recall letter dated April 15, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take one of the following options immediately to address the issue. 1) Customers can access a software update to resolve the issue at www.freestyleinsulinx.com/swupdate. 2) Customers can contact Abbott Diabetes Care Customers Service at 1-866-723-2697 to expedite return and replacement of the affected product at no charge. For questions customers were instructed to call Abbott Diabetes Care Customers Service at 1-866-723-2697. For questions regarding this recall call 510-239-2775.
- Quantity
- 335,273 meters; 209,336 remain at firm.
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Part Numbers: 71142-70 71143-70 71145-70 71150-70: All serial and lot numbers.
- 510(k) numbers
- ["K120568"]
- PMA numbers
- not on file
- Product code
- NBW
- 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