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-12-01-25-732
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Idylla™ Instrument
الأجهزة المتأثرة
REF: P0010 UDI-DI: 05415219000119 Please refer to the attachment for details of production identfier.
الممثل المعتمد
Advance Test Est.
سبب المشكلة
It has been identified by Biocartis that false-positive MSI-H test results could be, or could have been, generated by the Idylla™ MSI Test at your laboratory for the affected Idylla™ Instruments.
الإجراء التصحيحي
1. A service intervention for the affected Instrument(s) will be performed by A Biocartis representative. 2. Following an assessment of Idylla™ MSI Test run data for the affected Instrument(s), a service intervention may be performed. 3. A Biocartis representative will contact you and provide details on when and how the (potential) service intervention will be performed. Until your Instrument, listed in the attachment, is serviced, please move forward with the option that applies to your situation in the part "Actions to be taken by the customer) of the attachment. Manufacturer Action: Instructions and Correction.
المرفقات
عودة للقائمة
