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U.S. Department of Health and Human Services

Class 2 Device Recall Genuine One Touch Test Strips

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  Class 2 Device Recall Genuine One Touch Test Strips see related information
Date Initiated by Firm October 08, 2002
Date Posted December 31, 2002
Recall Status1 Terminated 3 on September 07, 2005
Recall Number Z-0399-03
Recall Event ID 25193
Product Classification Colorimeter, Photometer, Spectrophotometer For Clinical Use - Product Code JJQ
Product Genuine One Touch Glucose 50 Test Strips, For the quantitative measure of glucose in whole blood, LIFESCAN, a Johnson & Johnson Company, Milpitas California 95035, For Sale Outside of the USA and Canada, Lot 1666680A Exp. 2003-11. Product is packed two vials of 25 strips per vial.
Code Information Lot# 1666680A Exp. 2003-11
Recalling Firm/
Manufacturer		 River City Drug
1800 Sandy Plains Pkwy
Bldg 100 Suite 112
Marietta GA 30066
For Additional Information Contact Customer Service Department
800-579-5280
Manufacturer Reason
for Recall		 Products labeled 'For Sale Outside The USA and Canada,' were being offered for sale in the U.S.
FDA Determined
Cause 2		 Other
Action Letters were sent via regular mail to customers on/about 10/08/02 with a response card attached. Customers were informed of the recall, and were urged to contact their accounts and to return their outstanding recall stock to River City Drug for full credit.
Quantity in Commerce 3024 units
Distribution Nationwide. AZ, CA, DE, FL, GA, KY, KS, HI, IA, IL, LA, MA, MD, MI, MN, MO, NC, NM, NV, OH, OK, PA, SC, SD, TN, TX, VA, WA, WI, WV. There are no foreign or government accounts involved.
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.
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