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تسجيل جديد
الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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EN
SA-19-06-25-934
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
aPTT Screen cobas t 600T, aPTT Lupus cobas t 600T, aPTT cobas t 600T
الأجهزة المتأثرة
GMMI / Part No Device Identifier/ UDI-DI: 07153716190 aPTT Screen cobas t 600T UDI-DI: 07613336119853 07153678190 aPTT Lupus cobas t 600T UDI-DI: 07613336119846 07153589190 aPTT cobas t 600T UDI-DI: 07613336119853
الممثل المعتمد
Roche Diagnostics Saudi Arabia Limited
سبب المشكلة
Potential of detecting carryover from PT Rec and PT Rec-based factor assays (FII, FV, FVII, FX) to aPTT assays (aPTT, aPTT Lupus and aPTT Screen).
الإجراء التصحيحي
Customers are requested to mount the heated probe according to the maintenance workflow or user assistance. Special attention is required during the mounting of the heated probe (Also see the attachment). In addition, to ensure correct results for samples with aPTT Screen clotting times >50 sec, customers are requested to keep the already implemented reflex test and to make sure to have the latest carryover file installed (carryover evasion files are automatically installed with SW 2.3.0 or higher). See instructions in the attachment, aPTT Screen IFU and user assistance. Manufacturer action: Instructions and correction.
المرفقات
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