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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 Recall
FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM
see related information
Date Posted September 01, 2009
Recall Status1 Open
Recall Number Z-1936-2009
Recall Event ID 52427
Premarket Notification
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, California 94502-7000
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
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NBW and Original Applicant = ABBOTT DIABETES CARE INC.
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