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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 Recall
Life Scan One Touch Ultra
see related information
Date Posted February 14, 2007
Recall Status1 Terminated on January 07, 2008
Recall Number Z-0477-2007
Recall Event ID 36932
Product Classification System, Test, Blood Glucose, Over The Counter - 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, New Jersey 08816-2048
For Additional Information Contact Seth Grumet
732-698-9991
Manufacturer Reason
for Recall
Counterfeit Test Strips (manufacturer unknown)
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Counterfeit
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 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.
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