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Warning Date
    2015-05-05

Saudi Food and Drug Authority warns from using OneTouch® Verio® IQ blood glucose meter (home use)

2015-05-05

تود الهيئة العامة للغذاء والدواء ممثلة بقطاع الأجهزة و المنتجات الطبية أن تحذر المستهلك من استخدام جهاز قياس نسبة السكر في الدم طراز ون تتش فريو أي كيو (OneTouch® Verio® IQ) للاستخدام المنزلي والذي يصنع من قبل شركة  لايف سكان جونسون آند جونسون (Lifescan Johnson & Johnson Company)

حيث علمت الهيئة من خلال الشركة المصنعة للجهاز عن قيامها بسحبه واستبداله وذلك للأسباب التالية:

  • To report sector-related issues

  • Call Centre 19999


Other Warnings

Warning Date
    2015-09-10

SFDA Alerts About Error in ‘First Step’ Pregnancy Test Instructions for Use

2015-09-10

SFDA alerted users about a mistake in the Arabic Translation of the Instructions for Use, attached to home ‘First Step Plus’ Pregnancy Test Device with Lot No. C6-130417, thus leading to erroneous interpretation of the test result.

SFDA clarified that the device, manufactured by ‘Aid Diagnostic’, is used for early detection of pregnancy by determining HCG hormone in urine samples, pointing out that a mistake occurred in Lot No.

  • To report sector-related issues

  • Call Centre 19999


Other Warnings

Warning Date
    2015-06-04

SFDA Recommended Protective Actions to Patients of Implanted KAMPRA™ Lense

2015-06-04

SFDA recommended protective procedures to patients of implanted KAMPRA™  Lenses in case they undergo laser operations , or Femtosecond Laser, or Retinal Laser Photocoagulation operations for removal of Glaucoma .
SFDA clarified that AcuFocus ™  Inc. Company, the manufacturer of  KAMPRA™ Lenses, has updated their circuited notice dated 27 Sha’ban 1435H, to reflect the additional protective actions for patients of implanted KAMPRA™  Lenses applications .

  • To report sector-related issues

  • Call Centre 19999


Other Warnings

Warning Date
    2015-06-04

SFDA" warns about an error in "Easy Vision contact Lenses" size (-6.5)

2015-06-04

SFDA warned of correcting lenses made by "Easy Vision" size (-6.5) batch number R0031987, because packaging of the affected contact lenses is incorrectly mentioned as size (-6.5), while the real size is (-4.5). 

  • To report sector-related issues

  • Call Centre 19999


Other Warnings

Warning Date
    2015-05-05

SFDA Closed Out Five Violating Medical Products Stores in Dammam

2015-05-05

 

 

SFDA continues with its surveillance and control campaigns to medical devices and products stores and closed out 5 violating stores in Dammam, only after few days from taking the same decision against 7 other stores in Riyadh making the total number of the closed out store 32, in 40 days.

 

  • To report sector-related issues

  • Call Centre 19999


Other Warnings

Warning Date
    2015-05-05

SFDA Alerts about Defective Insulin Pumps for Treatment of High Blood Sugar (Diabetes)

2015-05-05

 

 

SFDA alerted the users of ‘Animas Vibe’ Insulin Pump, produced by Animas Corporation, and used for continuous injection of insulin ‘under the skin’ for treatment of high blood sugar, as the pump may cause loss of air evacuation alert, blockage  of pumping alert and pump inability to recognize insulin pack.

 

In a statement, SFDA referred to the model numbers of the affected insulin pumps as follows:

 

  • To report sector-related issues

  • Call Centre 19999


Other Warnings

Warning Date
    2015-05-26

SFDA Alerts about Inaccurate Recommendations of Accu-Chek® Connect Application for Diabetes Management

2015-05-26

 

 

SFDA alerted users  of Accu-Chek® Connect Application for Diabetes Management on Smart Phones, that the application may give inaccurate recommendations for the  insulin dosage, leading to potential risks to user’s  health when adopting such recommendations.

  • To report sector-related issues

  • Call Centre 19999


Other Warnings

Warning Date
    2015-05-26

"SFDA" seizes an 58 thousand contrary medical products in the 29 cities

2015-05-26

 

  • To report sector-related issues

  • Call Centre 19999


Other Warnings

Warning Date
    2015-05-26

"SFDA" closed seven violated stores that sell medical devices in Riyadh

2015-05-26


 

 

 

SFDA Inspectors in cooperation with police and the General Directorate of Health Affairs closed 7 shops selling medical equipment and supplies in Riyadh, for committing several offenses.

 

 

  • To report sector-related issues

  • Call Centre 19999


Other Warnings

Warning Date
    2015-05-26

SFDA Alerts about Inaccurate Recommendations of Accu-Chek® Connect Application for Diabetes Management

2015-05-26

 

SFDA alerted users  of Accu-Chek® Connect Application for Diabetes Management on Smart Phones, that the application may give inaccurate recommendations for the  insulin dosage, leading to potential risks to user’s  health when adopting such recommendations.

  • To report sector-related issues

  • Call Centre 19999


Other Warnings

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