تسجيل الدخول
تسجيل جديد
الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
عن تيقظ
بحث عن منتج
تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-21-01-25-751
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
IMMULITE 2000 Analyzer & IMMULITE 2000 XPi Analyzer
الأجهزة المتأثرة
Assay: IMMULITE 2000 EBV-VCA IgM Catalog Number: L2KEM2 Siemens Material Number/Unique Device Identification: 10488005/ 000630414999845 Lot Number | Manufacturing Date | Expiration Date: 408 | 29-May-2024 | 30-Nov-2024 409 | 08-Jul-2024 | 31-Dec-2024 410 | 23-Aug-2024 | 22-Jan-2025 411 | 30-Oct-2024 | 23-Mar-2025
الممثل المعتمد
ALKAMAL IMPORT OFFICE
سبب المشكلة
The potential for low adjustor indexes and out of range Quality Control after approximately 4 months from the reagent manufacturing date for the affected products.
الإجراء التصحيحي
• For the product(s) listed in the above, please perform the following steps: • You may continue to report EBV-VCA IgM patient results when in-range Quality Control results are obtained. • If in-range Quality Control results cannot be obtained, you may request no-charge replacement product from Siemens Healthineers representative. Please review your inventory of these products and assess your laboratory’s replacement needs. • Please retain the attachment with your laboratory records. Manufacturer action: instruction and removal.
المرفقات
عودة للقائمة
