التفاصيل - تيقظ

الرقم المرجعي

الشركة الصانعة

اسم الجهاز الطبي

الأجهزة المتأثرة

الممثل المعتمد

سبب المشكلة

الإجراء التصحيحي

If you have installed software version 4.5.0, you are requested to install patch v4.5.1 on your Erytra analyzer, which is already available and can be remotely installed, or to install software version v4.6.1, which will be available for installation in the next weeks.
If you have installed software version 4.6.0, you are requested to install software version 4.6.1 on your Erytra analyzer, which will be available for installation in the next weeks.
Until the software update is completed, the auto-export configuration must be deactivated. All results should be manually reviewed in the Test Details tab within the Results menu to verify that there are no duplicate executions of the technique. If a duplicate execution is found, the corresponding sample profile should be rejected and the execution repeated.
Additionally, a review of the customer analyzer database will be conducted by a Technical Service Representative of Diagnostic Grifols to detect any potentially affected result since the installation of version 4.5.0.

Manufacturer's Action: Instructions and Correction.

المرفقات

مسجل لدى هيئة الحكومة الرقمية برقم:

SA-22-09-25-1063