تسجيل الدخول
تسجيل جديد
الجمعة - ذو القعدة 11, 1446
عن تيقظ
بحث عن منتج
تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-25-07-24-530
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
BD Phoenix™ M50 & BD Phoenix™ 100 Instruments
الأجهزة المتأثرة
BD Phoenix™ M50 instrument Product Code (REF): 443624, 44362409 Serial Number: All UDI: 00382904436247 BD Phoenix™ 100 Instrument Product Code (REF): 448100, 44810009 Serial Number: All UDI: 00382904481001
الممثل المعتمد
Becton Dickinson BV Saudi Limited Company
سبب المشكلة
There has been an increase in the number of complaints for Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix™ M50 instrument and BD Phoenix™ 100.
الإجراء التصحيحي
- Continue use of the instrument. However, confirmatory testing should be performed on any suspected E. coli misidentifications until BD is able to perform the remediation to correct the issue. - It is not necessary to review previous test results and no additional clinical actions are recommended. - For BD Phoenix™ M50 users: BD representative will contact your facility to schedule a service visit to provide an update to the PUD (Phoenix Update Data) and software to correct this issue. - For BD Phoenix™ 100 users: A BD representative will contact your facility regarding next steps.
المرفقات
عودة للقائمة
