FDA Medical Device Recalls (openFDA)
Abbott Diabetes Care, Inc.: Abbott brand FreeStyle Navigator, Receiver Warranty Kit, Blood Glucose Monitoring System, Part Number: 70789-01. The product is manufactured by Benchmark Electronics, 3535 Technology Drive NW, Rochester, MN and distributed by Abbott Diabetes Care, 1360 South Loop Road, Alameda, CA.
- Recall number
- Z-1196-2009
- Recalling firm
- Abbott Diabetes Care, Inc.
- Product
- Abbott brand FreeStyle Navigator, Receiver Warranty Kit, Blood Glucose Monitoring System, Part Number: 70789-01. The product is manufactured by Benchmark Electronics, 3535 Technology Drive NW, Rochester, MN and distributed by Abbott Diabetes Care, 1360 South Loop Road, Alameda, CA.
- Status
- Terminated
- Initiated
- 2008-11-01
- Posted
- 2009-05-20
- Terminated
- 2009-06-03
- Reason
- The product has the Units of Measure set to mmol/L rather than mg/dL. The blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
- Root cause
- Packaging process control
- Action
- The Consignees of the affected FreeStyle Navigator Receiver Kit was contacted via telephone, Federal Express or an Abbott representative beginning on November 1, 2008. Contact Customer Service at 1-866-597-5520 with further questions.
- Quantity
- 2 units
- Distribution
- US Distribution to states of NY and AZ.
- Lot, serial or model codes
- Lot Number: 01M2278; Serial Numbers: BAAH223-80915 and BAAH223-80182.
- 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