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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-23-01-25-759
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Atellica CH Analyzer and Atellica CI Analyzer
الأجهزة المتأثرة
11097620
الممثل المعتمد
Abdulrehman Algosaibi GTC
سبب المشكلة
In December 2023, Siemens Healthineers issued FSCA letter communicating the potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent. Customers were instructed to batch test Atellica CH IgM_2 samples.
الإجراء التصحيحي
• The root cause for the reagent instability has been identified and the manufacturing control system has been updated to ensure that there is no impact to future lots. The issue has been resolved, and beginning with lot 242315, batch testing of Atellica CH IgM_2 samples will no longer be required. Refer to the attachment. • Please review the attachment with your Medical Director. • If your laboratory is using a lot prior to lot 242315, you must continue to follow instructions in the previous FSCA letter ACHC24-01.A.OUS. • If your laboratory has lot 242315 or above, stop following the instructions in ACHC24-01.A.OUS. • Please retain the attachment with your laboratory records.. Manufacturer action: instructions and correction.
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