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U.S. Department of Health and Human Services

Class 2 Device Recall OneTouch SureStep Pro Test Strips

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 Class 2 Recall
OneTouch SureStep Pro Test Strips
see related information
Date Posted January 05, 2007
Recall Status1 Terminated on November 27, 2007
Recall Number Z-0453-2007
Recall Event ID 36774
Premarket Notification
510(K) Numbers
K022724  K023194 
Product Classification Glucose Oxidase, Glucose - Product Code CGA
Product LifeScan brand One Touch -Sure Step Pro- 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 2634187008, Part number 010-797-02
Recalling Firm/
Lifescan Inc
1000 Gibraltar Dr
Milpitas, California 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
DESIGN: Device Design
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 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 = CGA and Original Applicant = LIFESCAN, INC.