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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott brand FreeStyle Navigator

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 Class 2 Device Recall Abbott brand FreeStyle Navigatorsee related information
Date Initiated by FirmNovember 01, 2008
Date PostedMay 20, 2009
Recall Status1 Terminated 3 on June 03, 2009
Recall NumberZ-1196-2009
Recall Event ID 50202
PMA NumberP050020 
Product Classification Sensor, glucose, invasive - Product Code MDS
ProductAbbott 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.
Code Information Lot Number: 01M2278; Serial Numbers: BAAH223-80915 and BAAH223-80182.
FEI Number 3002803444
Recalling Firm/
Manufacturer		 Abbott Diabetes Care, Inc.
1360 S Loop Rd
Alameda CA 94502-7000
For Additional Information ContactTina Mazurkiewicz
510-749-5400
Manufacturer 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.
FDA Determined
Cause 2		Packaging process control
ActionThe 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 Commerce2 units
DistributionUS Distribution to states of NY and AZ.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA DatabasePMAs with Product Code = MDS
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