​Saudi Food and Drug Authority represented by the medical devices sector  would like to warn all  healthcare practitioners from using OneTouch® Verio® Pro+ blood glucose meters (hospital and clinics use), manufactured by Lifescan Johnson & Johnson company due to incorrect test results stored in results log at extremely high blood glucose levels  above 1023 mg/dL (56.83 mmol/l).
SFDA has become aware through Lifescan Johnson & Johnson that recalling and replacing all OneTouch Verio Pro+ blood glucose meters because:
1- The meters are not working as expected when measuring a blood glucose level above 1023 mg/dL (56.83 mmol/l)
2- The meter will display a correct high value warning, but will record incorrect low glucose results in the memory at extremely high blood glucose levels above 1023 mg/dL (56.83 mmol/l)
3- The hazard associated with this issue is inaccurately low blood glucose results when using the meter memory to retrieve blood glucose results.
SFDA assures the implementation of corrective actions for OneTouch® Verio® Pro+ blood glucose meters with the manufacturer authorized representative.

Saudi Food and Drug Authority encourages all  to report any adverse event associated with medical devices through the National Center for Medical Devices Reporting :
 

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