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U.S. Department of Health and Human Services

Class 1 Device Recall One Touch Ultra test strips

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 Class 1 Recall
One Touch Ultra test strips
see related information
Date Posted January 05, 2007
Recall Status1 Terminated on December 22, 2009
Recall Number Z-0206-2007
Recall Event ID 36690
Product Classification System, Test, Blood Glucose, Over The Counter - Product Code NBW
Product One Touch Ultra Blood Glucose test strips, LifeScan, a Johnson & Johnson Co., 50 test strips, 2 vials of 25 test strips
Code Information Lot No. 2691191
Recalling Firm/
Manufacturer
Discount Diabetic Supply
1420 N Lamar Blvd Ste 102
Oxford, Mississippi 38655
For Additional Information Contact Steven Kincaid
800-533-7957
Manufacturer Reason
for Recall
Counterfeit-blood glucose test strips (manufacturer unknown)
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Counterfeit
Action The recalling firm notified its consignees of the problem and the recall by telephone on 10/19/2006. The firm followed this with a written notice on 10/30/2006.
Quantity in Commerce 240 units
Distribution Nationwide distribution --- States of CA, TX, TN, GA, AL, and OK
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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