Date Initiated by Firm |
November 01, 2008 |
Date Posted |
May 20, 2009 |
Recall Status1 |
Terminated 3 on June 03, 2009 |
Recall Number |
Z-1196-2009 |
Recall Event ID |
50202 |
PMA Number |
P050020 |
Product Classification |
Sensor, glucose, invasive - Product Code MDS
|
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.
|
Code Information |
Lot Number: 01M2278; Serial Numbers: BAAH223-80915 and BAAH223-80182. |
Recalling Firm/ Manufacturer |
Abbott Diabetes Care, Inc. 1360 S Loop Rd Alameda CA 94502-7000
|
For Additional Information Contact |
Tina 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 |
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. |
Total Product Life Cycle |
TPLC Device Report
|
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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.
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PMA Database |
PMAs with Product Code = MDS and Original Applicant = Abbott Laboratories
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