تسجيل الدخول
تسجيل جديد
الأربعاء - شوال 4, 1446
عن تيقظ
بحث عن منتج
تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-26-03-25-831
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
HemosIL® AcuStar ADAMTS13 Activity
الأجهزة المتأثرة
Part Number 0009802048 All Product Lots
الممثل المعتمد
Abdulla Fouad For Medical Supplies and Services Company
سبب المشكلة
New clarification and closure to previous reports of serious injury in patients where HemosIL AcuStar ADAMTS13 Activity results were below the medical decision level (< 10% activity), while a comparator assay reported results above the medical decision level.
الإجراء التصحيحي
- Review the HemosIL AcuStar ADAMTS13 Activity labeled intended use. - Evaluate patient results based on the clarifications in the part "Upcoming IFU Updates" of the attachment and best practices. - Assess whether additional testing is necessary before taking clinical action for results that are inconsistent with other clinical or laboratory findings. The Instructions for Use (IFU) for HemosIL AcuStar ADAMTS13 Activity will be updated in future lots to include the IFU Updates. Manufacturer action: Instructions and correction.
المرفقات
عودة للقائمة
