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تسجيل جديد
الثلاثاء - ربيع الآخر 22, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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EN
SA-09-09-25-1040
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Atellica CH Urinary/Cerebrospinal Fluid Protein
الأجهزة المتأثرة
Assay: Atellica CH Urinary/Cerebrospinal Fluid Protein Test Code: UCFP Siemens Material Number / Unique Device Identification: 11097543 / 00630414279206 All Lots
الممثل المعتمد
Abdulrehman Algosaibi GTC
سبب المشكلة
The potential for falsely depressed patient, quality control (QC), and/or calibration results with the Atellica CH UCFP assay.
الإجراء التصحيحي
Customers are to: - As an interim measure, keep only one (1) Atellica CH UCFP reagent pack onboard the system at a time. - Unload any Atellica CH UCFP packs that are currently onboard the system. - Perform QC on each well following instructions provided in the "“Appendix” section of the attchment, refer to the part of "Customer Actions" for more information. - Review the attachment with the Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. A follow-up communication will be provided by Siemens when “Customer Actions” are no longer required. Manufacturer Action: Instruction
المرفقات
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