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Urgent Medical Device Correction
SureStep®Pro® Test Strips
For Reference by Healthcare Practitioners and Distributers of SureStep®Pro® Test Strips Only
May 05, 2010
Frequently Asked Questions:
- Q: What caused the SureStep®Pro® Test Strip issue and how was it resolved?
A: The root cause was traced to a component lot of the raw materials used in the strip manufacturing process. This raw material has been replaced and verified on the manufacturing line. All SureStep®Pro® Test Strip lots with an expiration date of November 2011 or later are using this new material and are not affected.
- Q: What steps are you taking to ensure this doesn’t happen again?
A: We have extensive quality systems and procedures in place to thoroughly investigate each issue and subsequently develop corrective and preventive actions. For example, a new release test specification was introduced for glucose readings above the labeled dynamic range of 0-500mg/dL.
- Q: How do I know if I have received a new, unaffected lot?
A: All SureStep®Pro® Test Strip lots with an expiration date of November 2011 or later are not affected.
- Q: Can I order new SureStep®Pro® Test strips that are not affected?
A: Yes, all SureStep®Pro® Test Strips currently manufactured are not affected. These products have expiration dates of November 2011 or later.
- Q: Can I return my Critical High protocol threshold to 500mg/dL?
A: You can set a Critical High protocol threshold of 500mg/dL for all unaffected lots of SureStep®Pro® Test Strips, including all newly manufactured SureStep®Pro® Test Strip lots. These newly manufactured products have expiration dates of November 2011 or later. To determine if you have any affected lots, please click here. If you have any affected product, and you choose to continue to use it, you should maintain a “Critical High” protocol threshold of no more than 400 mg/dL.
- Q: How do I know if my lot is affected?
A: Please click here to input your lot number and determine whether or not your lot is affected.
- Q: If I am still using affected lots in my hospital, do I still need to set the critical high to no greater than 400mg/dL?
A: Yes. Until you use up or replace your affected test strips with new unaffected test strips, you should maintain a “Critical High” protocol threshold of no more than 400 mg/dL.
- Q: How do I return my unopened boxes of affected test strips and when can I expect credit to my account?
A: If you are a Hospital or Distributor that purchases directly from LifeScan, you may now return affected SureStep®Pro® Test Strips to LifeScan for a credit and place a new order for replacement product. Hospitals that purchase from a distributor should contact their distributor for return instructions. Be advised that this is not a mandatory market removal of affected product. Hospital customers may choose to use up their remaining supply of affected product as long as they maintain a “Critical High” protocol threshold of no more than 400 mg/dL.
- If you wish to make a return, please confirm that you have affected SureStep®Pro® Test Strips by clicking here. Only SureStep®Pro® Test Strips with affected lot numbers are eligible for return.
- Once you have collected all affected product you wish to return call 336-499-8180 for a Returned Goods Authorization (RGA) number and product return instructions.
- When we receive your returned product, we will issue a credit memo for an amount equivalent to your invoiced price of the returned product. No unauthorized deductions will be allowed. Allow 2 weeks from the date in which the product arrives to the return facility to receive your credit.
- Place a new order for replacement test strips. All new, unaffected shipments of SureStep®Pro® Test Strips will have expiration dates of November 2011 or later.
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