LifeScan Inc has issued a recall of its OneTouch® Verio®IQ, OneTouch Verio®Pro and OneTouch Verio®Pro+ blood glucose meters across the UK and Ireland, as part of a global voluntary recall. Registered users, healthcare professionals and pharmacies are being notified of the recall, which has been put into place with immediate effect.
It has emerged that the products do not operate effectively at blood glucose levels over 56.8 mmol/L (considered to be exceptionally high). LifeScan has determined that blood glucose levels are incorrectly displayed and stored at this level in the OneTouch Verio Pro Meter. In addition, the OneTouch Verio IQ meter is likely to switch off after detecting blood glucose levels above 56.8 mmol/L and the OneTouch Verio Pro+ may store an incorrect blood glucose measurement despite displaying the correct warning message.
Although it is unlikely that people with diabetes would experience blood glucose values of over 56.8 mmol/L, immediate medical attention is required in the event of extreme blood glucose elevation. Improper detection of high glucose levels could lead to delayed or incorrect treatment for hyperglycaemia, possibly resulting in injury.
Dr Michael Pfeifer, LifeScan’s Chief Medical Officer, said: “The safety of our patients is our highest priority. When we learn that a product does not fully meet our expected standards, we will voluntarily notify our regulators, customers and patients and take corrective action. We regret an difficulties these actions may cause; however, we will always err on the side of caution and act in the best interests of our patients.”
All users should seek additional information about this recall at: www.lifescan.co.uk/recall.
