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U.S. Department of Health and Human Services

Class 2 Device Recall FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM

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  Class 2 Device Recall FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM see related information
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  
Product Classification System, test, blood glucose, over the counter - Product Code NBW
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
For Additional Information Contact
510-749-5400
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.
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
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.
510(K) Database 510(K)s with Product Code = NBW and Original Applicant = ABBOTT DIABETES CARE INC.
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