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U.S. Department of Health and Human Services

Class 2 Device Recall OneTouch SureStep Test Strips

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 Class 2 Recall
OneTouch SureStep Test Strips
see related information
Date Posted March 17, 2009
Recall Status1 Open
Recall Number Z-1070-2009
Recall Event ID 50471
Premarket Notification
510(K) Number
K022724 
Product Classification System, Test, Blood Glucose, Over The Counter - Product Code NBW
Product OneTouch SureStep Test Strips, Part numbers 020-052-01 and 010-359-04, for use with SureStep brand Blood Glucose Meters, manufactured by LifeScan Inc., Milpitas, CA
Code Information Lot codes 2802961 and 2802962
Recalling Firm/
Manufacturer
Lifescan Inc
1000 Gibraltar Dr
Milpitas, California 95035
Manufacturer Reason
for Recall
Deformity in the test strip may result in insufficient blood transfer to reaction area, resulting in inaccurate test results.
FDA Determined
Cause 2
DESIGN: Process Design
Action Urgent: Medical Device Recall letters, dated 11/24/2008 were issued to all consignees on November 25, 2008, requesting return of affected lots to LifeScan and instructing how to obtain replacement strips free of charge. A request for sub-recall communications were made as well, and the firm posted notification on its website. Customer service and Sales account reps were provided information to address questions regarding the recall.
Quantity in Commerce 23,288 vials
Distribution Worldwide Distribution -- USA and the Caribbean.
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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