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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-16-03-25-815
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
DxI 9000 Access Immunoassay Analyzer
الأجهزة المتأثرة
REF: C11137 UDI: 15099590732103 SW 1.20.0 and below
الممثل المعتمد
Beckman Coulter Saudi Arabia Co Ltd
سبب المشكلة
- This issue affects DxI 9000 analyzers that are run with the system software versions listed above and are connected to a host system (laboratory information system (LIS) or middleware). - If a DxI 9000 analyzer has accumulated canceled QC test results that were not sent to the host system, the analyzer may lose communication with the host system. The lost connection cannot be restored by routine troubleshooting. - Sample processing is affected when the DxI 9000 analyzer loses communication with the host system.
الإجراء التصحيحي
To Prevent the Issue: Each time that the Cleaning Routine maintenance procedure is due, Beckman Coulter recommends that your laboratory perform the steps provided in Appendix A in the attachment before performing the Cleaning Routine. If the Issue Occurs: - If the DxI 9000 analyzer loses communication with the host system and does not generate an event message, perform the steps provided in Appendix A in the attachment to restore communication with the host system. - If the DxI 9000 analyzer loses communication and generates an event message, follow the system event troubleshooting steps on the user interface to restore the LIS connection. If the troubleshooting steps do not resolve the event, perform the steps provided in Appendix A in the attachment to restore communication with the host system. - Samples can be run on a different analyzer to prevent further delay to reporting patient results. Manufacturer action: Instructions and correction.
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