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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 Device Recall FreeStyle and FreeStyle Lite Blood Glucose Monitoring Test Stripssee related information
Date Initiated by FirmMarch 13, 2009
Date PostedFebruary 15, 2011
Recall Status1 Terminated 3 on February 15, 2011
Recall NumberZ-1258-2011
Recall Event ID 51399
510(K)NumberK051839 
Product Classification System, test, blood, glucose, over the counter - Product Code NBW
ProductFreeStyle 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/
Manufacturer		 Abbott Diabetes Care, Inc.
1360 S Loop Rd
Alameda CA 94502-7000
For Additional Information ContactJeffrey Deming
510-749-6364
Manufacturer Reason
for Recall		Product dispositioned for destruction was potentially diverted to end users.
FDA Determined
Cause 2		Other
ActionThe 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 Commerce1860 units
DistributionThe 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 CycleTPLC 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) Database510(K)s with Product Code = NBW
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