تسجيل الدخول
تسجيل جديد
الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
عن تيقظ
بحث عن منتج
تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-01-06-25-917
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Alinity i Total PSA Reagent Kit
الأجهزة المتأثرة
List Number (Lot Number): 07P9220 (71210FZ00, 71210FZ01, 71343FZ00, 73728FZ00, 73155FZ00, 73155FZ01, 73298FZ00) 07P9230 (71213FZ00, 71346FZ00, 73162FZ00) UDI: Refer to the attachment.
الممثل المعتمد
Medical Supplies and Services Co Ltd
سبب المشكلة
It has been identified by Abbott a performance issue with the Alinity i Total PSA Reagent Kits, regarding the lots listed above. Potential for both out-of-range third-party quality control (QC) results and a positive bias in patient sample results when using specific product lots.
الإجراء التصحيحي
- Immediately discontinue use of the Alinity i Total PSA Reagent Kit lots listed above. - Destroy all inventory of the impacted lot numbers according to your local procedures. - Please review the attachment with your Medical Director or Laboratory Manager and follow your laboratory protocol regarding the need for review of previously reported patient results using the impacted lot numbers. Manufacturer Action: Instructions and removal.
المرفقات
عودة للقائمة
