Date Initiated by Firm |
November 01, 2006 |
Date Posted |
December 29, 2006 |
Recall Status1 |
Terminated 3 on September 25, 2012 |
Recall Number |
Z-0265-2007 |
Recall Event ID |
36696 |
Product Classification |
Blood Glucose Test Strips - Product Code CGA
|
Product |
OneTouch Basic/Profile Blood Glucose test strips. For use with One Touch Brand Meters blood glucose meters |
Code Information |
Lot # 272894A, 2619932, 2606340, and 2615211 |
Recalling Firm/ Manufacturer |
Royal Global Wholesale 5681 Northpointe Lane Boynton Beach FL 33437
|
Manufacturer Reason for Recall |
Counterfeit Glucose Test Strips (manufacturer unknown)
|
FDA Determined Cause 2 |
Other |
Action |
The firm notified its consignees by phone and issued a recall letter on 11/3/2006. Consumers who have the product were advised to destroy the product or return it to the retail outlet where it was purchased. |
Quantity in Commerce |
1,600 |
Distribution |
Worldwide |
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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