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تسجيل جديد
الاثنين - رجب 23, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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أسئلة شائعة
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EN
SA-28-07-24-535
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Flow Cytometer XF-1600
الأجهزة المتأثرة
UDI-DI: 04987562509997 REF: AD629376 Serial numbers affected: all
الممثل المعتمد
Sysmex LLC One Person Co
سبب المشكلة
A potential risk of incorrect result measurement that could lead to incorrect treatment decision.
الإجراء التصحيحي
A Sysmex representative will contact you for providing the immediate action, refer to the attachment for more information, until that follow the below: 1. Until a Sysmex representative visits you, please start at position 3 or later for autoloader measurements when acquiring data on the XF-1600. If you are using PS-10, please create a worklist so that the sample you want to measure is preprocessed at rotor position 3 or later. Remark: PS-10 cannot skip position 1 and position 2, so create a worklist with dummy samples for these positions. 2. Review the content of the attachment with your facility's physician and/or pathologist and retain it for any future reference. 3. Sysmex advises you to consult your facility's physician and/or pathologist to determine any clinical implications (including retrospective review and/or re-testing) specific to your patients.
المرفقات
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