التفاصيل - تيقظ

الرقم المرجعي

الشركة الصانعة

اسم الجهاز الطبي

الأجهزة المتأثرة

الممثل المعتمد

سبب المشكلة

الإجراء التصحيحي

Please review the attachment with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable.
• Repeat samples with cTnI results above 0.07 ng/mL or your institution’s established 99th percentile value
    o As mentioned above, there is a potential for false positive results when using cTnI TestPaks any time during shelf life; therefore, as an additional measure, customers are advised to perform repeat testing of samples when the cTnI result is above 0.07 ng/mL or your institution’s established 99th percentile value.
    o As recommended in the Acute Care™ cTnI TestPak Instructions for Use (IFU), a test result that is inconsistent with the clinical picture and patient history should be interpreted with caution. Furthermore, results should be interpreted as part of serial sampling at admission.
• Siemens will reimburse users for repeat tests and discarded cTnI TestPaks associated with this field corrective action. 

Manufacturer action: Instructions and removal.

المرفقات

مسجل لدى هيئة الحكومة الرقمية برقم:

SA-20-04-25-864