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تسجيل جديد
الأربعاء - ربيع الآخر 23, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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EN
SA-13-11-24-673
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Atellica® CI 1900 Analyzer
الأجهزة المتأثرة
Material Number / UDI: 10947347 / 00630414229560
الممثل المعتمد
Abdulrehman Algosaibi GTC
سبب المشكلة
The IMT Diluent volume remaining (% remaining) does not decrease as expected on the Atellica® CI Analyzer. The IMT module runs a Standard A refresh sequence before processing samples if at least two minutes of inactivity have passed. IMT Diluent is used by this sequence, however, the calculated diluent volume is not accurate, potentially leading to the IMT Diluent being empty while still displaying that volume is remaining. In this case Sodium (Na), Potassium (K) and Chloride (Cl) test results may be falsely elevated. Quality Control materials demonstrate the same behavior.
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. Customer to follow the instructions provided in the attachment. Atellica CI Analyzer software version 1.29.x and higher resolves the behavior described in the attached letter. After installing software version 1.29.x customers should reset the IMT Fluid Volume Threshold (%) to the laboratory’s preferred threshold. Manufacturer Action: Instructions and Correction.
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