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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-04-03-25-800
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Alinity m System
الأجهزة المتأثرة
Alinity m System: List Number (UDI): 08N53-01 ((01)00884999047389), 08N53-02 ((01)00884999048034) Alinity m System Refurbished : List Number (UDI): 08N53-32 ((01)00884999047587) SW version: V1.8.1 or lower
الممثل المعتمد
Medical Supplies and Services Co Ltd
سبب المشكلة
Three potential performance issues: - The sample input camera may falsely recognize primary tubes as secondary tubes. - Integrated Reaction Units (IRUs) may become double stacked during processing if the an IRU was moved out of the position when Sample Processing Unit Processor (SPUP) initializing occurred. - In the scenario a user manually creates an order with a Sample ID (SID) that exceeds the twenty (20) character maximum as described in the operator manual and then repeatedly attempts to onboard the order, it may cause lack of tracking of expiration for reagents, calibrators, controls, and specimens.
الإجراء التصحيحي
Abbott representative will schedule a mandatory upgrade of your Alinity m System software. Please refer to "Actions Until Mandatory Upgrade is Complete" in the attachment. Manufacturer action: Instructions and correction.
المرفقات
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