RecallDepth

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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