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Terminated

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.

FDA Recall Z-1196-2009 · Posted 2009-05-20

Recalling FirmAbbott Diabetes Care, Inc.
Recall StatusTerminated
Product CodeMDS
Date Initiated2008-11-01
Date Terminated2009-06-03
Product Quantity2 units

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.

Firm 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.

Root Cause

Packaging process control

Distribution Pattern

US Distribution to states of NY and AZ.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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