تسجيل الدخول
تسجيل جديد
الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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بحث عن منتج
تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-18-02-25-791
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Anti-TPO
الأجهزة المتأثرة
Product Code: ORG 203
الممثل المعتمد
Rustom Medical Company
سبب المشكلة
Following an internal performance evaluation it has been confirmed that performance claims in the current Instructions for Use (IFU) are not met. The outcome of an internal evaluation showed a clinical Sensitivity of 42.7% instead of 96.9% as claimed in the IFU. The Overall Agreement is 52.6% instead of 97.9% as claimed in the IFU.
الإجراء التصحيحي
- Identify and destroy the product - Follow-up of patients or review of patient’s previous results are recommended. - If symptoms are suggestive of thyroid dysfunction, but Anti-TPO test is negative, doctors may consider additional testings, like Anti-TG antibodies or Anti-TSH receptor antibodies. They may also focus on thyroid function tests (TSH, Free T3, T4) and clinical examinations. Manufacturer action: Instructions and Removal.
المرفقات
عودة للقائمة
