RIYADH, Saudi Arabia, May 23, 2013 /PRNewswire/ --
At extremely high glucose levels (1024 mg/dl and above), the meters will not operate as intended, which could potentially delay the diagnosis and proper treatment of severe hyperglycemia
LifeScan, Inc., the manufacturer of OneTouch® Verio® Meters, is initiating a voluntary recall and replacement of its OneTouch® Verio® IQ and OneTouch® Verio® Pro blood glucose meters in the Kingdom of Saudi Arabia, effective immediately. This recall does not affect the OneTouch®Select® or the OneTouch® Ultra® range of meters which users can continue to use with confidence.
In full collaboration with Saudi Food & Drug Authority (SFDA), LifeScan is recalling and replacing all OneTouch® Verio IQ® and OneTouch® Verio® Pro meters because at extremely high blood glucose levels of 56.8 mmol/L and above, the meters do not operate as intended.
The number of affected meters in the Kingdom of Saudi Arabia is estimated to be very low if any as the products have not been available for sale or prescription in the Kingdom.
At LifeScan, we hold our products to the highest standards of quality and are committed to communicating with patients and healthcare professionals when we learn that our products do not fully meet our expected standards. We are working very closely with the Saudi Food & Drug Authority (SFDA), in conducting this recall and fully support the actions being taken by the Kingdom of Saudi Arabia Food and Drug Authority in relation to this issue.
Immediate actions users should take, depending on their OneTouch® Verio® model:
OneTouch® Verio® IQ Meter:
- Contact LifeScan Customer Service at 8002440266 to make arrangements to receive a replacement meter at no charge and to speak with a LifeScan representative. Representatives are available Saturday to Wednesday 0700 - 1600 GMT. In addition, we will be open Thursday and Friday this week before reverting to normal hours next week.
- Please note: Patients may continue to test with their OneTouch® Verio® IQ meters while they wait for their replacement meter to arrive as long as they are aware of this issue. LifeScan advises that if the meter unexpectedly turns itself off during testing, this could be a sign of extreme hyperglycemia requiring immediate medical attention and the patient should call a health care professional. However as the OneTouch® Verio® IQ Meter is not registered or authorized in Saudi, we strongly recommend to replace the meter immediately.
OneTouch® Verio® Pro Meter:
- Discontinue use of this meter immediately and use another method for testing blood glucose
- Contact LifeScan Customer Service at 8002440266to make arrangements to receive a replacement meter at no charge and to speak with a LifeScan representative. Representatives are available Saturday to Wednesday 0700 - 1600 GMT. In addition, we will be open Thursday and Friday this week before reverting to normal hours next week.
Only the OneTouch® Verio®IQ and OneTouch® Verio® Pro meters are impacted by this issue. All other OneTouch® Brand products, including OneTouch® Select® and the OneTouch® Ultra® (meters and test strips) are not affected and can continue to be used with confidence.
Actions the company is taking globally
Notifications are being sent to all registered users, healthcare professionals, pharmacies and distributors wherever these products are sold around the globe.
This recall impacts three OneTouch® Verio® Brand Meters globally
Three OneTouch® Verio® Meters are being recalled globally because of incorrect glucose value display or record storage at extremely high glucose levels: OneTouch® Verio® IQ, OneTouch® Verio® Pro and the OneTouch® Verio® Pro+ Meters. LifeScan has notified and is working with the individual regulatory agencies around the world where these products have been sold. To date, no adverse events or patient injuries related to this issue have been reported globally for the OneTouch® Verio® IQ and OneTouch® Verio® Pro+ Meters. For the OneTouch® Verio® Pro Meter, LifeScan has received one report of a serious adverse event. The company has not determined whether the OneTouch® Verio® Pro meter was a causal factor.