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Counterfeit OneTouch® Ultra™ Test Strips discovered in Greece
October 18, 2006
If you use, recommend, distribute or sell OneTouch Ultra™ Test Strips, we want to make you aware that we have recently discovered several incidents of counterfeit test Strips in Greece. The counterfeit products are intended for use with the OneTouch Ultra™ monitors. We have identified the distributor who has brought the product into Greece and are working with them to recall the affected lot.
This issue does not involve OneTouch® OneTouch® SureStep® or Smart Scan™ Test strips.
Potential Risk to Patients
Performance testing of the counterfeit test strips obtained by LifeScan to date shows erratic test results that do not meet LifeScan's performance specifications. It is unknown how counterfeit test strips which may be in the marketplace will perform. LifeScan cannot ensure the accuracy and reliability of blood glucose test results obtained from test strips it did not manufacture. Patients should discontinue use of these counterfeit test strips and replace them immediately. Patients should also contact their physician to assess potential treatment implications. Use of these counterfeit test strips could result in inaccurate test results that may lead to improper treatment. For example, insulin treatment based on inaccurate blood glucose results could result in serious injury or death.
Lifescan Greece, a division of Johnson & Johnson Hellas is working closely with the Greek Health Authorities (ministry of Health, Welfare & Social Services, National Organization for Medicines) and other relevant authorities on this matter. Identifying Counterfeit Product
Counterfeit OneTouch Ultra™ Test Strips
The counterfeit test strips are difficult to differentiate from the genuine OneTouch Ultra™ strips as the packaging closely mimics that offered in Greece by LifeScan. However, the counterfeit product can be identified by the following characteristics:
- Lot number currently associated with the counterfeit product is 2625258
- Expiry date printed of 07/2007
What You Should Do
People With Diabetes:
If you discover you have counterfeit OneTouch® Ultra™ Test Strips, discontinue use of these counterfeit test strips and call LifeScan Customer Service at 210-6875770 or 2310-392301 or 8001178888 (free toll number) or through E-mail: service@cscgr.jnj.com
Doctors:
Please share this information with your patients with diabetes that use OneTouch Ultra™ Blood glucose monitors. For additional information contact LifeScan Customer Service at 210-6875770 ,2310-392301 or 8001178888 (free toll number) or through E-mail: service@cscgr.jnj.com
Pharmacies/Retailers:
We recommend you routinely check your inventory of OneTouch® Ultra™ Test Strips. If you identify counterfeit product based on the characteristics listed in this letter, please report your discovery immediately by calling Lifescan Customer Service at 210-6875770, 2310-392301 or 8001178888 (free toll number), or by contacting your sales representative.
Ask your patients that have received these counterfeit strips to return them to you for verification and replacement as necessary. Please be aware that LifeScan will not issue credit for counterfeit products. For restitution, you will need to contact your original source of supply for these test strips.
Your report will aid regulatory and law enforcement agencies in their ongoing investigation into the sources of these counterfeit products.
Sincerely
Nikos Sotirhos
Country Manager
Lifescan Greece
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