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تسجيل جديد
الثلاثاء - ربيع الآخر 22, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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أسئلة شائعة
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EN
SA-17-03-25-817
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Atellica CH and Atellica CI Analyzers
الأجهزة المتأثرة
Assay: Atellica CH Revised C-Reactive Protein (RCRP) Test Code: RCRP Siemens Material Number/Unique Device Identification: 11537223/00630414610887 All lots
الممثل المعتمد
Abdulrehman Algosaibi GTC
سبب المشكلة
Incorrect software flagging may occur for the Atellica CH RCRP assay that may potentially lead to an erroneous result.
الإجراء التصحيحي
- Please review the attachment with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. - For both Atellica CH and Atellica CI analyzers, perform the instructions in Appendix B to temporarily reduce the measuring interval. Until the measuring interval is restored, track additional reagent consumption as a result of these actions to report to Siemens Healthineers for future reimbursement/credit. - Additionally, for Atellica CH Analyzers, perform the instructions in Appendix C to remove rules for flagging of “No Calculation” results and to install Atellica Solution Software version 1.29.0 or higher. Manufacturer action: Instructions. Updated Action: For the Atellica CI, Please refer to the appendix D for instructions in the attachment (ACHC24-07.D.OUS).
المرفقات
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