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السبت - جمادى الأولى 17, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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EN
SA-04-11-25-1131
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
BD BACTEC™ MGIT™ 960 PZA Kit
الأجهزة المتأثرة
Product Code (REF): 245128 Basic UDI-DI: 038290OPKQGYUDKE Manufacturer’s SRN: US-MF-000018910
الممثل المعتمد
Becton Dickinson BV Saudi Limited Company
سبب المشكلة
It was identified that old production of the above affected product, may intermittently produce falsely resistant results for pyrazinamide (PZA) during susceptibility testing of Mycobacterium tuberculosis isolates.
الإجراء التصحيحي
BD is announcing they have resumed production of a modified version of the BD BACTEC™ MGIT™ 960 PZA Kit which includes modified inoculation methods and reduced shelf-life. BD has conducted a thorough review of the performance from all supported inoculum sources using the synthetic raw material and the following change has been implemented for the BD BACTEC™ MGIT™ 960 PZA Kit. • Only inoculum prepared from MGIT tubes 3-5 days post-positivity can be currently supported. • Inoculum prepared from MGIT tubes 1-2 days past instrument positivity are currently not supported. • Inoculum prepared from solid media are currently not supported. Additionally, the shelf life of the product has been adjusted from 18 months to 13 months to reflect the latest internal supporting data. Customer Actions: • Review the information in the attachment. Manufacturer's Action: Correction.
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