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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-04-09-25-1033
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
ID-Anti-S - Test serum ID-Anti-M, N, S, s, Fya, Fyb
الأجهزة المتأثرة
Please refer to the attachment Product name (Product UDI, Catalog Number, Manufacture Date, Expiry Date): ID-Anti-S (07611969069514, 007132, 25.02.2025, 31.07.2026) Batch/Lot Number(s): 0033454701 IHD Display Batch: 09010.47.01 Product name (Product UDI, Catalog Number, Manufacture Date, Expiry Date): ID-Anti-M, N, S, s, Fya, Fyb (07611969069552, 008712, 19.11.2024, 30.04.2026) Batch/Lot Number(s): 0050103803 0076423804 0076443805 0076463806 IHD Display Batch: 45460.38.03/ 08630.47.02 45460.38.04/ 08630.47.02 45460.38.05/ 08630.47.02 45460.38.06/ 08630.47.02
الممثل المعتمد
Abdulrehman Algosaibi GTC
سبب المشكلة
A quality issue related to false positive reactions obtained with Bio-Rad anti-S test serum.
الإجراء التصحيحي
1) Check your inventory for any remaining of the affected lots. 2) If you find any affected product, dispose following your internal protocol. 3) Contact Bio-Rad to request replacement for any of the affected products. 4) If any patients or donors were tested with the affected lots and received a positive result, consult with your medical director to decide if further testing or other steps are needed. Manufacturer's Action: Removal.
المرفقات
عودة للقائمة
