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U.S. Department of Health and Human Services

Class 1 Device Recall Life Scan One Touch Ultra

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  Class 1 Device Recall Life Scan One Touch Ultra see related information
Date Initiated by Firm October 09, 2006
Date Posted February 14, 2007
Recall Status1 Terminated 3 on January 07, 2008
Recall Number Z-0477-2007
Recall Event ID 36932
Product Classification Blood Glucose Test Strips - Product Code NBW
Product One Touch Ultra Blood Glucose Test Strips-Lot # 2691191, LifeScan
Code Information One Touch Ultra Test Strips: Lot #'' 2691191.
Recalling Firm/
Manufacturer		 Matrix Distributors, Inc.
110 Tices Ln
Unit 5B
E Brunswick NJ 08816-2048
For Additional Information Contact Seth Grumet
732-698-9991
Manufacturer Reason
for Recall		 Counterfeit Test Strips (manufacturer unknown)
FDA Determined
Cause 2		 Other
Action Matrix Distributors contacted by telephone those pharmacies to which they had shipped the affected lots. These call were conducted from 10/9 to 10/13/2006. A follow-up letter was issued to the pharmacies extending the recall to the user level.
Quantity in Commerce 800 units
Distribution Product was distributed to 96 pharmacies throughout the United States.
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.
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