It has come to our attention that medical device manufacturer, LifeScan, has initiated a field safety corrective action concerning OneTouch Select Control Solution. The affected lot numbers are 2AA1D01 and 2AA2D02.
LifeScan is voluntarily removing and replacing two lots of OneTouch Select Control Solution distributed in Russia, Ukraine and Republic of Moldova. The purpose of Control Solution Testing is to confirm that the meter and test strips are working together correctly as a system. The lots of control solution are being replaced because they may not provide an "in range" control test result when used with OneTouch Select Test Strips, even though the system is working correctly. As the meter's User Guide and Control Solution instructions for use state, an out of range Control Solution test result may mean the meter system is not working properly. This may lead to a delay further blood sugar testing. This issue applies to control solution test results only. The accuracy of patient blood sugar test results is not affected.
The manufacturer advises users to immediately discontinue use of the affected products and contact their supplier for product replacement. It also advises users that if having control solution from the affected lots, they may continue to use the blood glucose system while waiting for replacement.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 28 February 2013