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السبت - جمادى الآخرة 8, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-22-09-25-1064
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
DxC 500i Clinical Analyzer
الأجهزة المتأثرة
REF: C13252 UDI: 15099590742331 Software: SW v1.3.5 and lower
الممثل المعتمد
Beckman Coulter Saudi Arabia Co Ltd
سبب المشكلة
The affected products may fail to apply a dilution factor to tests associated with a manually diluted sample when the tests are ordered through the Test Order Entry page and a unique sample ID is not used.
الإجراء التصحيحي
• When ordering tests for a manually diluted sample through the Test Order Entry page, a unique sample ID is required. • Alternatively, use the Dilute and Rerun feature or an automated dilution to measure diluted samples. Refer to Rerunning a Test with a Diluted Sample in the System Help for more information. • Share the attachment with your Medical Director to determine if performing a retrospective review of results is necessary. • Beckman Coulter will implement a correction with a future software release. • Your Beckman Coulter service representative will contact you to schedule the software upgrade when it is available. Manufacturer's Action: Instructions and Correction.
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