التفاصيل - تيقظ

الرقم المرجعي

الشركة الصانعة

اسم الجهاز الطبي

الأجهزة المتأثرة

الممثل المعتمد

سبب المشكلة

الإجراء التصحيحي

- Customers can continue to use the affected device, but should perform a visual check of the rinse tubing immediately.
- In addition, please perform a visual check of the Reaction Cells Wash tubing when executing the monthly operator maintenance action “Replace Reaction Cells”. Please refer to the attachment.
- In case you identify any damage on the tubing, please report the damage to your local Roche Service Representative.
- No general recommendations with respect to the review of previous results can be given by using the cobas c703 analytical unit. Customers should follow their standard laboratory operating procedures. Any specific questions raised by the users should be addressed individually, considering all relevant clinical information.

To prevent occurrences of premature deterioration to the Reaction Cells Wash tubing Roche Diagnostics’ Service Team will schedule additional service visits to replace tubing that is older than 6 months.

Manufacturer's Action: Instructions and Correction.

المرفقات

مسجل لدى هيئة الحكومة الرقمية برقم:

SA-07-12-25-1168