Alert on Counterfeit "One Touch" Glucose Test Strips

FDA is alerting healthcare professionals and patients about counterfeit blood glucose test strips which are being sold for use with various models of LifeScan's One Touch blood glucose monitors. LifeScan says that its testing of the counterfeit strips shows erratic test results. These 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.

The counterfeit test strips have been identified as certain lots labeled as "One Touch Ultra" or "One Touch Basic/Profile". To date, the counterfeit product has been limited to 50-count packages for both products.

For the 50-count packages of One Touch Ultra test strips, the counterfeit version will have all three of the following characteristics:

• Lot Numbers 2691191 or 2691261
• Multiple languages - the outer carton is in both English and French.
• No NDC number (normally located on the bottom of the outer carton for US product)

For the 50-count packages of One Touch Basic/Profile test strips with lot numbers 272894A, 2619932 or 2606340, the counterfeit version will have the following characteristics:

• Multiple languages - the outer carton is in English, Greek and Portuguese.
• No NDC number (normally located on the bottom of the outer carton for US product)

For the 50-count packages of One Touch Basic/Profile test strips with lot numbers 2615211 or 227078A, the counterfeit version will have the following characteristics:

• Only English appears on the outer carton.
• Counterfeit vial is labeled "plasma calibrated."

The counterfeit test strips were distributed to pharmacies and stores nationwide, but primarily in Ohio, New York, Florida, Maryland and Missouri. Consumers who have the counterfeit test strips should stop using them, replace them immediately and contact their physician. Health care professionals should alert patients who use these test strips about the possibility of counterfeiting. Pharmacists and retailers should check their inventories routinely. For additional information, contact LifeScan at 1-866-621-4855.

Category:

News & Politics

Tags:

• One
• Touch
• Glucose
• Test
• Strips
• FDA
• Counterfeit
• LifeScan
• Diabetes
• Patient
• Safety