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Class 2 Device Recall FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM |
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Date Initiated by Firm |
June 10, 2009 |
Date Posted |
September 01, 2009 |
Recall Status1 |
Terminated 3 on January 10, 2011 |
Recall Number |
Z-1936-2009 |
Recall Event ID |
52427 |
510(K)Number |
K070850
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Product Classification |
System, test, blood glucose, over the counter - Product Code NBW
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Product |
FreeStyle Lite Blood Glucose Test Strips, CSP, 50's US, Checkpoint, FS Lite, for use with FreeStyle Lite Blood Glucose Meters and FreeStyle Freedom Lite Blood Glucose Meters, Part Number 70822-02, manufactured by Abbott Diabetes Care, Inc., Alameda, CA.
The product is used for testing outside the body (in vitro) diagnostic use, in the home and in professional settings to monitor blood glucose levels. |
Code Information |
Lot number 0822524, expiration date 2010/08. |
Recalling Firm/ Manufacturer |
Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda CA 94502-7000
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For Additional Information Contact |
510-749-5400
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Manufacturer Reason for Recall |
Low results: Freestyle Lite Blood Glucose Test strip may generate low blood glucose readings when tested with the control solution from lot 0822524 with Freestyle Freedom Lite and Freestyle Lite Blood Glucose Meters.
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FDA Determined Cause 2 |
Process control |
Action |
An "Important: Medical Device Notification" letter dated June 10, 2009 was issued to consignees. First consignees received notifications via letters to both direct consignees and registered customers of FreeStyle Lite and FreeStyle Freedom Lite blood glucose meter users in the states where the affected test strip lot was distributed. Affected accounts and customers were instructed to discontinue distribution and use of the product. The notification will be posted to the Abbott Diabetes Care website. Direct questions about the recall to Abbott Diabetes Care, Inc. by calling 510-749-5400. |
Quantity in Commerce |
9,252 vials |
Distribution |
US only (states AL, AZ, CA, FL, GA, IL, IN, MD, NJ, NY, OH, PA, RI, SC, TN, TX and WI). |
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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510(K) Database |
510(K)s with Product Code = NBW and Original Applicant = ABBOTT DIABETES CARE INC.
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