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تسجيل جديد
الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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EN
SA-22-07-24-524
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
VITROS® Immunodiagnostic Products Folate Reagent Pack 1/2
الأجهزة المتأثرة
Affected Product Name: VITROS Immunodiagnostic Products Folate Reagent Pack 1/2 Product Code (Unique Device Identifier): 1513266 (10758750009237) Impacted Product Name: VITROS Immunodiagnostic Products Vitamin B12/Folate Reagent Pack 3 Product Code (Unique Device Identifier): 1142561 (10758750008476) VITROS Immunodiagnostic Products Red Cell Folate Pack Product Code (Unique Device Identifier): 1107804 (10758750008407)
الممثل المعتمد
Samir Trading and Marketing CJSC
سبب المشكلة
Potential generation of condition code “TM5-4MA” or “TM5-4MB” when testing the VITROS Folate on VITROS 3600 Immunodiagnostic Systems and VITROS 5600/XT 7600 Integrated Systems.
الإجراء التصحيحي
If retesting the sample leads to subsequent “TM5-4MA” or “TM5-4MB” condition codes, it may not be possible to generate a result with this sample on the VITROS 3600 Immunodiagnostic Systems or VITROS 5600/XT 7600 Integrated Systems. Please use serum samples instead of plasma if repeat “TM5-4MA” or “TM5-4MB” condition codes are noted with a particular patient plasma sample, refer to the attachment for more information.
المرفقات
عودة للقائمة
