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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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EN
SA-06-04-25-840
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
BIOFIRE® Blood Culture Identification 2 (BCID2) Panel
الأجهزة المتأثرة
Reference Numbers: RFIT-ASY-0147 (30-pack)
الممثل المعتمد
ALJEEL MEDICAL COMPANY
سبب المشكلة
-‘Not Detected’ Candida tropicalis results when testing the BIOFIRE BCID2 Panel with MMQCI Control Panel M416. -Increased risk of false positive Candida tropicalis results when the BIOFIRE® Blood Culture Identification 2 (BCID2) Panel (Part No.: RFIT-ASY-0147) is used with BD BACTECTM Blood Culture Vials.
الإجراء التصحيحي
- Update your BIOFIRE BCID2 Panel Pouch Module software: The updated BIOFIRE BCID2 Panel Pouch Module Software and instructions for installation can be downloaded here: https://www.biofiredx.com/e-labeling/ITIFA20BCID210. Please use the English version and read the technical note before installation. This technical note and installation download cannot be opened via Firefox browser; please use a different browser. - Distribute the attachment and the updated BIOFIRE BCID2 Panel IFU revision 06 (downloaded from e-labeling website: https://www.biofiredx.com/e-labeling/ITI0048) to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties that may use this product, including others to whom you may have transferred our product. Manufacturer action: Instructions and correction.
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