Update Dec 12, 06

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Update Dec 12, 06

December 12th 2006: One more FDA class 1 recall of Counterfeit One Touch blood glucose strips

On October 13, 2006, the U.S. Food and Drug Administration (FDA) alerted the public to counterfeit blood glucose test strips being sold in the United States for use with various models of LifeScan, Inc., One Touch Brand Blood Glucose Monitors. Counterfeit One Touch® Basic®/Profile® Blood Glucose Test Strips and Counterfeit One Touch® Ultra® Blood Glucose Test Strips were joined these series of recalls and were initiated on October 17th and October 19th respectively.

Counterfeit One Touch® Basic®/Profile® Blood Glucose Test Strips are counterfeit versions of LifeScan’s products. These counterfeit test strips could give incorrect blood glucose values, either too high or too low, which might result in a patient taking either too much or too little insulin. This could lead to serious injury or death.

Counterfeit One Touch® Ultra® Blood Glucose Test Strips are counterfeit and they were found to give erratic results that do not meet the manufacturer’s specifications. This could lead to serious injury or death.

Lot numbers of counterfeit blood strips are as follows:

Counterfeit One Touch® Basic®/Profile® Blood Glucose Test Strips Lot Numbers are 272894A, 2619932, 2606340,

One Touch® Ultra® Blood Glucose Test Strips, LifeScan, Lot Number is 2691191
Consumers who have the counterfeit test strips should stop using them, replace them immediately and contact their physician. Consumers with questions may also contact LifeScan at: 1-866-621-4855.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

For complete FDA report of this update, please refer to following links:
http://www.fda.gov/cdrh/recalls/recall-101706.html
http://www.fda.gov/cdrh/recalls/recall-101906.html
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01497.html

If you have comments regarding this update, please contact Romil Rambhia at 516-482-9001 or email at romil@mdiconsultants.com

For any questions about this article, please Email Romil Rambhia at romil@mdiconsultants.com

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