تسجيل الدخول
تسجيل جديد
الثلاثاء - ربيع الآخر 22, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
عن تيقظ
بحث عن منتج
تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-20-08-25-1017
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
VIDAS® FPSA
الأجهزة المتأثرة
Ref. 30440 Please refer to the attachment for more details.
الممثل المعتمد
ALJEEL MEDICAL COMPANY
سبب المشكلة
An overestimation of FPSA results when using the affected products.
الإجراء التصحيحي
• Follow the guidance below: o For new testing performed with the impacted lots, you can continue using the kits by applying a corrected threshold described in the attachment. o For patient results obtained between May 2023 to current using the impacted lots, bioMérieux suggests you discuss any concern you may have with your laboratory director or your clinician to potentially review the result applying the corrected thresholds detailed in the attachment. Results should be reviewed and interpreted in the overall clinical context as this test is an aid of diagnosis. Manufacturer action: Instructions.
المرفقات
عودة للقائمة
