The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning OneTouch Verio Pro, OneTouch Verio IQ, and OneTouch Verio Pro+ blood glucose meters, manufactured by Lifescan.
Regarding OneTouch Verio Pro and OneTouch Verio Pro+, at blood glucose levels of 33.3 mmol/L] and above, the Meter should display a warning that says "EXTREME HIGH BG above [33.3 mmol/L]." However, at extremely high blood glucose levels of [56.8 mmol/L] and above, the Meters will display and store in memory an incorrect test result that is [56.8 mmol/L] below the measured result.
Regarding OneTouch Verio IQ, at extremely high blood glucose levels of 56.8 mmol/L and above, the 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. However, if the glucose level is still 56.8 mmol/L or above when testing, the meter will shut down again.
Both of the above situations can cause delay in the diagnosis of severe hyperglycemia. The manufacturer advises patients to discontinue use of this meter immediately and use another meter for testing their blood glucose. Furthermore, LifeScan will be conducting a global recall to remove all of the affected meters from the market.
According to the local supplier, the affected products were not distributed in Hong Kong.
For details, please refer to MHRA website
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON249653
If you are in possession of the product, please contact your supplier for necessary actions.
Posted on 26 March 2013