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Lifescan recalls certain OneTouch Verio blood glucose meters

LifeScan, the manufacturer of OneTouch Verio Meters, is initiating a voluntary recall and replacement of its OneTouch Verio Pro, OneTouch Verio IQ, and OneTouch Verio Pro+ blood glucose meters in the UK and Ireland, effective immediately.

This is because at extremely high blood glucose levels of 56.8 mmol/l and above, the meters do not operate as intended. This could lead to incorrect treatment or delay proper treatment of extreme hyperglycaemia, potentially resulting in serious injury. While the likelihood of experiencing an extremely high blood glucose level of 56.8 mmol/l or higher is rare, when such a blood glucose level occurs, it is a serious health risk requiring immediate medical attention.

Meters affected

OneTouch Verio IQ Meter

At extremely high blood glucose levels of 56.8 mmol/l and above, the OneTouch Verio IQ Meter will turn off instead of displaying the message "Extreme High Glucose above 33.3 mmol/l" as intended.

When turned back on, the meter enters the Set-up mode and requires the user to confirm the date and time settings before being able to test again. If the glucose level is still 56.8 mmol/l or above when testing, the meter will shut down again.

OneTouch Verio Pro Meter

At blood glucose levels of 33.3 mmol/l and above, the OneTouch Verio Pro Meter should display a warning that says "Extreme High BG above 33.3 mmol/l". LifeScan has recently determined that at extremely high blood glucose levels of 56.8 mmol/l and above, the OneTouch Verio Pro Meter will display and store in memory an incorrect test result that is 56.8 mmol/l below the measured result.

OneTouch Verio Pro+ Meter

The OneTouch Verio Pro+ Meter is a blood glucose monitoring system used by healthcare professionals and is not available to people with diabetes for personal blood glucose testing. For further information see theLifeScan website.

Actions to be taken by users

Depending on their OneTouch Verio model, users should take the following actions immediately:

OneTouch Verio IQ Meter

Contact LifeScan Customer Service at 0800 279 9118 (UK) or 1800 535 676 (Ireland) to make arrangements to receive a replacement meter at no charge and to speak with a LifeScan representative. Representatives are available 8am–6pm Monday–Friday and 9am–1pm Saturday.

Please note: People 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 hyperglycaemia and the person should seek immediate medical attention.

OneTouch Verio Pro Meter

Discontinue use of this meter immediately and use another meter for testing your blood glucose.

Contact LifeScan Customer Service at 0800 279 9118 (UK) or 1800 535 676 (Ireland) to make arrangements to receive a replacement meter at no charge and to speak with a LifeScan representative. Representatives are available 8am–6pm Monday–Friday and 9am–1pm Saturday.

Users should seek additional information about this recall at theLifeScan website.Customer Care Freephone:UK: 0800 121200Ireland 1800 535676.

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