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
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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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