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الجمعة - محرم 9, 1447
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EN
SA-14-01-25-735
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
ROTEM sigma complete & ROTEM sigma complete + hep
الأجهزة المتأثرة
ROTEM sigma complete. - Part No.: 555501 - Lot No.: S221203 ROTEM sigma complete + hep. - Part No.: 555502 - Lot No.: S221204 Exp. Date (YYYY-MM-DD): 2024-06-30
الممثل المعتمد
Abdulla Fouad For Medical Supplies and Services Company
سبب المشكلة
The FIBTEM C A5 results obtained with the current IVDR version exhibited a bias from measurements made with the previous IVDD version for a population within the Obstetric setting, leading to an adjustment in a bleeding management algorithm.
الإجراء التصحيحي
The manufacturer instructs the customers to follow these actions: - Check if you have established a bleeding management algorithm for ROTEM sigma, - If yes, verify the established bleeding management algorithm for a potential impact due to the bias between the IVDD and the IVDR cartridges and take appropriate validation actions for your algorithm following your internal procedures. Manufacturer action: Instructions.
المرفقات
عودة للقائمة
