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Warning Date
    2014-09-15

SFDA warns the use of Blood Glucose Test by (GenStrip) strips

2014-09-15

SFDA warned healthcare providers, diabetes patients and all the consumers from testing Blood Glucose by using (GenStrip) strips produced by Shasta Technologies, LLC that are designed to be used with (LifeScan OneTouch) devices series  only and not with other devices, because it gives false readings for blood sugar levels which may cause substantial risks to the patients health. SFDA confirms that (GenStrip) strips for Blood Glucose Test is not licensed by SFDA, and wasn't given the clearance through the points of entry. For the safety of diabetic patients and consumers who may have received such strips from other sources, SFDA recommends to stop using (GenStrip) for checking blood sugar, and to use alternative strips to check the blood sugar that conform with (LifeScan OneTouch) models, also to pay attention to the signs and symptoms of high blood sugar (Hyperglycemia) and low blood sugar (Hyporglycemia), furthermore, SFDA advises that when patients feel any symptoms they should go to the nearest health facility and inform SFDA in case of any presence of these strips, through the National Center for Medical Devices Reports (NCMDR)-  

 

 

Medical Devices
  • To report sector-related issues

  • Call Centre 19999


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