Urgent: Medical Device Correction
Affecting 1 Lot of OneTouch® Ultra® Test Strips - 2964512
February 4, 2010
Frequently Asked Questions:
Has the FDA been made aware of this issue?
Yes, the FDA has been made aware.
Are there any other affected lots of test strips?
The only US lot number affected by this notification are 100 count - OneTouch® Ultra® Test Strips with lot number 2964512.
I believe that I have had the affected lot # in the past that led to errors/inaccuracies with my meter. Will you still replace them?
I would be more than happy to help you resolve any issues you are having with your OneTouch products; however, without the affected test strip vial(s) in your possession I will be unable to replace them for you. As a safety feature, the affected strips will not turn on your OneTouch Ultra Brand meter or provide a test result so you were most likely using the correct strips. If you ever experience problems with any of your blood glucose materials, please call us right away so that we can expeditiously troubleshoot the issue at hand and replace items in a timely manner.
I do not have the affected lot number; however, I do have test strip vials which appear to not be working properly. What can you do for me?
Based on our current information, LifeScan is only replacing mislabeled vials from lot number (2964512). I will document your issue and handle it according to our current complaint documentation procedures, including replacing the product, if necessary.
I am a retailer/distributor/wholesaler and I have multiple boxes of these strips, will you replace them for me?
Due to the low incidence of 900 vials of mislabeled test strips and the inability to identify them without opening each carton, we request that you do not return any OneTouch Ultra Test Strips from the affected lot unless further notified by LifeScan to do so.
Please continue to sell and distribute any inventory you may have of 100-count One Touch Ultra Test Strips from lot # 2964512.
LifeScan has had a number of quality issues over the years, why should anyone use your products at all?
I can understand your concern. We know that patients rely on our products and services to help them manage their diabetes and we take this responsibility seriously. This is why we have extensive quality systems and procedures in place, including acting on customer feedback, so that we can quickly identify and notify our customers of any issue that could potentially affect the performance of our products. We also conduct extensive investigations into the cause of any issue and put corrective actions in place to prevent its reoccurrence. We hope our commitment to our customers and our actions on their behalf to protect patient safety will continue to make us worthy of your trust.
What steps are you taking to ensure that this doesn’t happen again?
We have extensive quality systems and procedures in place to thoroughly investigate each issue. We have already identified the cause of this error and have put corrective actions in place to address this issue.
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