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مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-03-08-25-985
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
DxC 500i Clinical Analyzer
الأجهزة المتأثرة
Product: DxC 500i Clinical Analyzer Configuration: With ISE Analyzer Module: DxC 500 AU Module w/ISE, DxC 500i REF: C63522 UDI:14987666545089 Configuration: Without ISE Analyzer Module: DxC 500 AU Module, DxC 500i REF: C63521 UDI:14987666545072 Software Version: SW 1.3.3 and 1.3.4
الممثل المعتمد
Beckman Coulter Saudi Arabia Co Ltd
سبب المشكلة
When ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test on the affected products, if the IA test is processed between the Clinical Chemistry constituent tests, the sample status of the Clinical Chemistry test will remain “In Progress” with no error events.
الإجراء التصحيحي
• This issue only impacts software versions 1.3.3 and 1.3.4. To check your software version, select Menu > About page. • For DxC 500i Clinical Analyzers running software version 1.3.3 or 1.3.4, if this issue occurs, you will need to place a new order for the CC combination test, - Select Home > Sample List task indicator, then select Active in the upper left corner of the Sample List to display samples “In Progress”. - Program the CC combination tests for these “In Progress” samples using a new rack and Sample ID, apply the new barcode, then load the rack onto the analyzer for processing. - Set aside the rack with “In Progress” samples and contact your Beckman Coulter representative to clear them. Manufacture Action: instructions and correction.
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