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.
- Company
- Abbott Diabetes Care, Inc.
- Recall Initiated
- November 1, 2008
- Posted
- May 20, 2009
- Terminated
- June 3, 2009
- Recall Number
- Z-1196-2009
- Quantity
- 2 units
- Firm Location
- Alameda, CA
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.
Distribution
US Distribution to states of NY and AZ.
Lot / Code Info
Lot Number: 01M2278; Serial Numbers: BAAH223-80915 and BAAH223-80182.
Root Cause
Packaging process control
Action Taken
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.
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