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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 Device Recall OneTouch SureStep Test Strips see related information
Date Initiated by Firm September 29, 2006
Date Posted January 05, 2007
Recall Status1 Terminated 3 on November 27, 2007
Recall Number Z-0452-2007
Recall Event ID 36774
510(K)Number K022724  
Product Classification Blood glucose test strips - Product Code NBW
Product LifeScan brand OneTouch Sure Step- Blood Glucose Monitoring System Test Strips, 50 strips per package,

Distributed and Manufactured by: LifeScan, Inc.,
1000 Gibraltar Drive, Milpitas, CA 95037
Code Information Lot number 2627353, part number 020-052-01
Recalling Firm/
Manufacturer		 Lifescan Inc
1000 Gibraltar Dr
Milpitas CA 95035-6312
Manufacturer Reason
for Recall		 Inaccurage test results: testing may lead to no test results, error message or inaccurately low test results.
FDA Determined
Cause 2		 Other
Action The firm has issued notification on 9/29/06 to consumers and hospital end users known to the firm and direct accounts that received the recalled product. The firm also posted the notice on the website, and customer service scripting was developed to notify callers.
Quantity in Commerce 26,398 units (both recall numbers Z-0452/3-2007
Distribution Nationwide to Al, AZ, CA, CN, DE, FL, GA, IL, IN, KT, KY, LA, MA, MD, MI, MN, MS, MO, NE, NJ, NM, and TX.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = NBW and Original Applicant = LIFESCAN, INC.
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