تسجيل الدخول
تسجيل جديد
الخميس - محرم 8, 1447
عن تيقظ
بحث عن منتج
تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-29-06-25-945
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Unsaturated Iron Binding Capacity (UIBC) Reagent
الأجهزة المتأثرة
REF: OSR61205 All Lots All Expiry Dates
الممثل المعتمد
Beckman Coulter Saudi Arabia Co Ltd
سبب المشكلة
The affected products fails to meet the hemolytic interference specification, as stated in the IFU.
الإجراء التصحيحي
• Sharing the attachment with your laboratory and/or Medical Director to evaluate the requirement for a retrospective review of UIBC results for hemolysed samples. • Discontinuance or disposal of this product is not necessary. • Per the IFU, avoid hemolysed samples when using the UIBC assay. If the LIH influence check setting for hemolysis has been enabled on AU/DxC AU instruments for UIBC, update the setting as descripes in the attachment. The IFU has been updated, please refer to the "RESOLUTION" in the attachment for more information. Manufacturer action: Instructions and correction.
المرفقات
عودة للقائمة
