تسجيل الدخول
تسجيل جديد
الجمعة - رمضان 14, 1446
عن تيقظ
بحث عن منتج
تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-04-08-24-541
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
IMMAGE Immunoglobulin M (IgM)
الأجهزة المتأثرة
Ref: 447610 UDI: 15099590221195 Lot (Expiry Date): M307362 (31May2025), M309410 (31Jul2025)
الممثل المعتمد
Beckman Coulter Saudi Arabia Co Ltd
سبب المشكلة
The IMMAGE Immunochemistry Systems IGM Immunoglobulin M reagent lots listed above are not meeting the sensitivity statement in the IFU: “Sensitivity is defined as the lowest measurable concentration which can be distinguished from zero with 95% confidence. Sensitivity for IGM determination is 4.2 mg/dL.”
الإجراء التصحيحي
- Discontinue use of affected IMMAGE Immunochemistry Systems IGM Immunoglobulin M reagent lots and please follow product replacement instructions in the attachment. - It has been recommended by Beckman Coulter sharing the content of the attachment with your laboratory and/or medical director regarding the need to perform a retrospective review of the patient results generated from the affected IMMAGE Immunochemistry Systems IGM Immunoglobulin M reagent lots to determine if retesting is necessary.
المرفقات
عودة للقائمة
