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U.S. Department of Health and Human Services

Class 1 Device Recall One Touch

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  Class 1 Device Recall One Touch see related information
Date Initiated by Firm October 14, 2006
Date Posted January 05, 2007
Recall Status1 Terminated 3 on June 06, 2007
Recall Number Z-0266-2007
Recall Event ID 36863
Product Classification Blood Glucose Test Strips - Product Code NBW
Product One Touch Basic/Profile and One Touch Ultra Blood Glucose Test Strips
Code Information One Touch Basic/Profile Lot #''s 2606340, 2619932, 272894A, 2615211 One Touch Ultra Lot #''s 2691191, 2691261
Recalling Firm/
Core Care Technologies, Inc
309 Fries Mill Rd., Suite 14
Sewell NJ 08080
For Additional Information Contact Ronald Manno
Manufacturer Reason
for Recall
Counterfeit product (manufacturer unknown)
FDA Determined
Cause 2
Action The firm identified the customers who had been sent OneTouch test strips since August 2006 and contacted each by phone to identify the lot number of the test strips in the customer's possession. A letter was sent on 11/21/2006 by first class mail which identified the lot numbers identified in the letter from the law firm and providing instructions to follow if the affected lots were found.
Quantity in Commerce unknown
Distribution Nationwide.
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.