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U.S. Department of Health and Human Services

Class 2 Device Recall One Touch Ultra Test Strips

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 Class 2 Recall
One Touch Ultra Test Strips
see related information
Date Posted November 21, 2008
Recall Status1 Open
Recall Number Z-0004-2009
Recall Event ID 49413
Premarket Notification
510(K) Number
K062195 
Product Classification System, Test, Blood Glucose, Over The Counter - Product Code NBW
Product One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Code Information Lot number 2829235
Recalling Firm/
Manufacturer
Lifescan Inc
1000 Gibraltar Dr
Milpitas, California 95035
Manufacturer Reason
for Recall
Products exceed inaccuracy threshold , with many complaints resulting from inaccurate low results.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Urgent: Medical Device Recall letters, dated 09/19/2008, were sent to consumer end users, direct account distributors and wholesalers, health care providers, and pharmacists notifying them of the recall. The letter states that if customers have strips from Lot 2829235, they should call LifeScan at 1-866-247-1281 and tell customer service that they have strips that need to be replaced. Customer service and QA scripts were provided to LifeScan staff to provide to any callers who inquire about the recall. The distributors and wholesalers were to locate and sequester any inventory from the affected Lot 2829235; request all recalled inventory from customers; call Carolina Logistics for an RGA; and when only the affected returned product is received, a credit will be issued.
Quantity in Commerce 35308 vials
Distribution Nationwide Distribution --- including Puerto Rico.
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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