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تسجيل جديد
الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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أسئلة شائعة
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EN
SA-13-08-24-558
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
BD FACSDuet™ Sample Preparation Systems
الأجهزة المتأثرة
Product Name (Product Code (REF), UDI-DI): BD FACSDuet™ Sample Preparation System (Base) (662588, 00382906625885) BD FACSDuet™ Premium Sample Preparation System (666339, 00382906663399) Serial Number: All serial numbers with BD FACSDuet™ software version 1.4.1
الممثل المعتمد
Becton Dickinson BV Saudi Limited Company
سبب المشكلة
It has been identified a specimen volume bias issue with the BD FACSDuet™ Sample Preparation System when using software version 1.4.1.
الإجراء التصحيحي
1. Identify Software Version installed in BD FACSDuet™ Sample Preparation System at your site, refer to Appendix 1 in the attachment. 2. Cease use of the BD FACSDuet™ Sample Preparation System with software version 1.4.1. until the Multidispense feature has been disabled. If not already disabled, refer to Appendix 2 in the attachment for instructions on how to disable the BD FACSDuet™ Sample Preparation System Multidispense feature. BD will schedule a mandatory upgrade of your BD FACSDuet™ Sample Preparation System software to version 1.4.2.
المرفقات
عودة للقائمة
