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OneTouch blood glucose test strips recalled by LifeScan Canada for faulty reading

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Friday, February 26, 2010, 17:54 This news item was posted in medical devices category and has 0 Comments so far.

LifeScan Canada Ltd is voluntarily recalling  3 lots of glucometer OneTouch SureStep Test Strips due to faulty readings in blood glucose levels in Canada.

Blood glucometer OneTouch SureStep Test Strips are used by people with diabetes to measure their blood glucose levels at home.

OneTouch SureStep Test Strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 22.2 mmol/L.

This recall is limited to three lots of OneTouch SureStep Test Strips sold for consumer use in Canada. Recalled lot are # 2966726, # 2966726, # 2983464 and # 2988755 of 100-ct size OneTouch SureStep.

Lot numbers are located on the outer carton and test strip vial.

Consumers using OneTouch SureStep Blood Glucose Monitoring Systems are asked to call LifeScan Canada at 1 866 339-3045 to find out if their test strips are affected. Replacement product will be shipped immediately and provided free of charge.

The patients are, however, advised to continue to test their blood glucose with recalled test strips while they wait for replacement product to arrive.

However, if they use these strips and receive a result of 22.2 mmol/L or higher from their OneTouch SureStep System, there is a possibility that their blood glucose is significantly higher.

If this occurs, patients should contact their healthcare professional for further instructions. Patients with a second meter that does not use OneTouch SureStep Test Strips can also retest their blood glucose to confirm their result.

No injuries associated with these recalled test strips have been reported.

Hospitals, clinics and other multi-patient facilities using SureStep Flexx or SureStep Hospital Systems have also been notified of this issue.

Both of these systems use SureStep Pro Test Strips which also may provide inaccurately low test results when the blood glucose reading is greater than 22.2 mmol/L.

LifeScan is advising these facilities of the appropriate actions to take in order to continue to use these SureStep Pro Test Strips.

However, healthcare facilities with access to alternative means of testing should consider temporarily discontinuing their use of their SureStep Systems until replacement test strips are available.

This field action is limited to three lots of OneTouch SureStep Test Strips sold for consumer use in Canada, and select SureStepPro Test Strips used in healthcare facilities. Similar recall actions are being taken in other countries where the affected product was distributed.

In 2006, LifeScan stopped selling OneTouch SureStep Meters in Canada but continued to provide test strips.

Today, OneTouch SureStep Meter users represent a very small portion of LifeScan’s total customer base. The vast majority of LifeScan’s customers now use OneTouch Ultra Brand Meters, which use an entirely different technology.

LifeScan is a leading maker of blood glucose monitoring systems for people with diabetes.

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