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Class 2 Device Recall One Touch Ultra Test Strips |
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Date Initiated by Firm |
September 19, 2008 |
Date Posted |
November 21, 2008 |
Recall Status1 |
Terminated 3 on December 27, 2010 |
Recall Number |
Z-0004-2009 |
Recall Event ID |
49413 |
510(K)Number |
K062195
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Product Classification |
Blood Glucose Test System - Product Code NBW
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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 CA 95035
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For Additional Information Contact |
408-942-5903
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Manufacturer Reason for Recall |
Products exceed inaccuracy threshold , with many complaints resulting from inaccurate low results.
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FDA Determined Cause 2 |
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
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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.
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510(K) Database |
510(K)s with Product Code = NBW and Original Applicant = LIFESCAN, INC.
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