Z-1196-2009

Abbott brand FreeStyle Navigator, Receiver Warranty Kit, Blood Glucose Monitoring System, Part Number...

Name: Z-1196-2009 Abbott brand FreeStyle Navigator, Receiver Warranty Kit, Blood Glucose Monitoring System, Part Number...
Creator: Abbott Diabetes Care, Inc.
Published: 2008-11-01
License: https://open.fda.gov/license/

Abbott Medical / initiated 2008-11-01 / Terminated / root cause: packaging

FDA source

Abbott Diabetes Care, Inc. began a recall of Abbott brand FreeStyle Navigator, Receiver Warranty Kit, Blood Glucose Monitoring System, Part Number: 70789-01. The product is manufactured by Benchmark... on 2008-11-01. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1196-2009
Status: Terminated
Initiated: 2008-11-01
Posted: 2009-05-20
Terminated: 2009-06-03
Recalling firm: Abbott Medical
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.
Product code: MDS Sensor, Glucose, Invasive
Reason for recall: 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 tag: packaging
FDA 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 in commerce: 2 units
Distribution: US Distribution to states of NY and AZ.
Product codes and lots: Lot Number: 01M2278; Serial Numbers: BAAH223-80915 and BAAH223-80182.

Product code MDS

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)