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الخميس - شوال 5, 1446
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SA-17-02-25-789
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Abbott RealTime HIV-1 Amplification Reagent Kit and Alinity m HIV-1 AMP Kit
الأجهزة المتأثرة
List Numbers: 02G31-010, 02G31-090, 06L18-090, and 08N45-090, 08N45-095 Not Lot Specific, See Appendix A for Unique Device Identifiers (UDIs)
الممثل المعتمد
Medical Supplies and Services Co Ltd
سبب المشكلة
In recent years, multiple gene therapies have been introduced that utilize HIV-1 based lentiviral vectors to deliver therapeutic genes to patients with hereditary or acquired diseases. Due to the use of conserved HIV-1 sequences in these lentiviral vectors, there is the potential for HIV-1 PCR assays to detect HIV-1 target in HIV-negative patients who have received these gene therapies, including those for chimeric antigen receptor (CAR) T-cells or hematopoietic stem cells.
الإجراء التصحيحي
In the Limitations of the Procedure section of the Instructions for Use for the Abbott RealTime HIV-1 and Alinity m HIV-1 assays, Abbott will be adding a statement around the use of their assays for patients receiving gene therapies that utilize HIV-1 based lentiviral vectors which may contain conserved HIV-1 sequences detected by their assays. Manufacturer action: Instructions.
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