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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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EN
SA-05-11-24-661
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Atellica CH Analyzer
الأجهزة المتأثرة
Product: Atellica CH Reaction Ring Cuvette Segment Siemens Material Number /Unique Device Identification: 11099326 / 00630414596143 Lot Numbers: All lots starting with “N15” or “15”. Please refer to the attachment for more details.
الممثل المعتمد
Abdulrehman Algosaibi GTC
سبب المشكلة
There is a potential for imprecision with seven (7) assays identified to have optical sensitivity when using a subset of lots of Atellica® CH Reaction Ring Cuvette Segments on some Atellica CH analyzers.
الإجراء التصحيحي
-Review your current Atellica CH Reaction Ring Cuvette Segment stock. All Atellica CH Reaction Ring Cuvette Segments beginning with “11” are not part of this communication and can be used without restriction. Any other lot in your stock must be immediately discarded. -Locate your analyzer’s serial number within Appendix B Serial Number List in the attachment. If your analyzer’s serial number is in the provided list perform the instructions to assess, inspect and/or replace Atellica CH Reaction Ring Cuvettes Segments provided in the Appendix section of the attachment, refer to it for more details. Manufacturer Action: Instructions and Removal.
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