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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-26-02-25-794
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
PF4 Enhanced® and PF4 IgG
الأجهزة المتأثرة
PF4 Enhanced: Product Number: 303287 / X-HAT13 (UDI Number:10888234500025), 303288 / X-HAT45 (UDI Number:10888234500032) PF4 IgG: Product Number: 303289 / HAT13G (UDI Number:10888234500049), 303290 / HAT45G (UDI Number:10888234500056) Refer to the attachment for Lot Number, Expiration Date.
الممثل المعتمد
Medical Supplies and Services Co Ltd
سبب المشكلة
The lot-matched Anti-Human IgG Conjugate (HAG) included with PF4 IgG kits and the lot-matched Anti- Human IgG/A/M (HAH) Conjugate included with the PF4 Enhanced kits have the potential to generate Positive Control Serum (HPC) mean OD values lower than the validity criteria of ≥ 1.800. These lower mean OD values would result in an invalid assay.
الإجراء التصحيحي
- You may continue to use the affected kit lot numbers using the acceptance criteria as labeled in the IFU for PF4 IgG and PF4 Enhanced kits. Assay results generating passing control values are considered valid. - Evaluate and monitor your rate of invalid assays. Contact the local representative if they observe an increased rate of invalid tests. - It is important to remind customers that assay results generated with passing controls are considered valid. There is no requirement to re-test samples from these runs. Manufacturer action: Instructions.
المرفقات
عودة للقائمة
