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U.S. Department of Health and Human Services

Class 2 Device Recall OneTouch SureStep

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 Class 2 Recall
OneTouch SureStep
see related information
Date Posted July 17, 2010
Recall Status1 Terminated on December 08, 2010
Recall Number Z-2027-2010
Recall Event ID 54565
Premarket Notification
510(K) Number
K022724 
Product Classification System, Test, Blood Glucose, Over The Counter - Product Code NBW
Product OneTouch SureStep and SureStep Pro Test strips, for use with the OneTouch SureStep Blood Glucose Meters, in 100 count and 50 count packaging distributed by LifeScan Inc., Milpitas, CA, Manufactured by LifeScan Puerto Rico Medical device for quantitative measurement of glucose in whole blood for use in home settings (SureStep).
Code Information Part Number 02005201 (100 count), lot numbers 2969798, 2969251, 2982369, 2983467; Part number 01035904 (50 count), lot numbers 2969795 and 2982566; Part number 02096401 (50 count mail order pack), lot numbers 2969481 and 2998193
Recalling Firm/
Manufacturer
Lifescan Inc
1000 Gibraltar Dr
Milpitas, California 95035
Manufacturer Reason
for Recall
Products may provide inaccurate results at readings over 400 mg/dL
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action The firm, Lifescan, Inc., issued two "Urgent Medical Device Recall" letters dated February 24, 2010 to all customers for the OneTouch SureStep Test Strips and the SureStep Pro Test Strips. The letters describes the product, problem and action to be taken by the customers. The customers were instructed to look at your test strip vials for the recalled lots and check the strips or if you have test strips from the lot, call LifeScan Customer Service at 800-574-6139 between 5 a.m. to 7 p.m. Pacific Time, seven days a week or visit www.SureStep.com. Replacement product will be shipped to you immediately at no charge. The customers were instructed to continue to test your blood glucose, while wafting for replacement. Also, the customers are asked to continue use of the meter with precautions if results over 400 units are observed. For more information, please visit www.SureStep.com or call our Healthcare Professional Line at 888-455-5627.
Quantity in Commerce 1,014,350
Distribution Worldwide distribution: USA and countries of Europe, Latin America and Asia.
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 = LIFESCAN, INC.
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