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U.S. Department of Health and Human Services

Class 2 Device Recall FreeStyle and FreeStyle Lite Blood Glucose Monitoring Test Strips

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 Class 2 Recall
FreeStyle and FreeStyle Lite Blood Glucose Monitoring Test Strips
see related information
Date Posted February 15, 2011
Recall Status1 Terminated on February 15, 2011
Recall Number Z-1258-2011
Recall Event ID 51399
Premarket Notification
510(K) Number
Product Classification System, Test, Blood Glucose, Over The Counter - Product Code NBW
Product FreeStyle Blood Glucose Monitoring System Test Strips and Freestyle Lite Blood Glucose Monitoring System Test Strips, for use with FreeStyle and FreeStyle Lite Test Strips respectively, 100 count, manufactured by Abbott Diabetes Care, Alameda, CA. Product is used with FreeStyle and FreeStyle Lite Blood Glucose Meters to measure glucose (sugar) in whole blood. The test strips are used for testing outside the body (in vitro diagnostic use). The FreeStyle Blood Glucose Monitoring Systems are intended for use in the home and in professional settings to monitor blood glucose levels.
Code Information Part number/Lot or Serial Number/Expiration dates: 70345-02, 70468-1/0803221/Feb 2010; 70468-05/0802523/Jan 2010; 70344-02/0802832, 0802823, 0802422/JAN 2010, 70827-01/0817617/Jun 2010; 70468-04/0718730/ July 2009; 70817-01/0812304/May 2010
Recalling Firm/
Abbott Diabetes Care, Inc.
1360 S Loop Rd
Alameda, California 94502-7000
For Additional Information Contact Jeffrey Deming
Manufacturer Reason
for Recall
Product dispositioned for destruction was potentially diverted to end users.
FDA Determined
Cause 2
Action The firm, Abbott Diabetes Care (ADC), will be posting notification on its Abbott Diabetes Care website. Also, the firm issued an "IMPORTANT: MEDICAL DEVICE NOTIFICATION" letter dated March 13, 2009, to customers ( registered users of Free Style, Free Style Flash, FreeStyle Freedom or Free Style Navigator). For foreign consignees/customers, the firm has issued communication worldwide. The letter described the product, problem and action to be taken by the customers. The customers were instructed to please check the lot number on the test strip carton or vial for the affected product number; if found, discontinue use and call the ADC Customer Care line at: 1-800-310-1500 and the ADC representative will provide information on how to return the test strips and arrange to have replacement test strips sent. If you have any questions, please call ADC Customer Care line at 1-800-310-1500.
Quantity in Commerce 1860 units
Distribution The firm, ADC, quarantined the eight lots and disposed them to scrap. These eight lots were not released from the firm ADC's control; therefore, the firm was unable to determine the number of consignees.
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.