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
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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
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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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