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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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EN
SA-14-09-24-590
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Xpert Xpress CoV-2 plus
الأجهزة المتأثرة
Catalogue Number: XP3SARS-COV2-10 Unique Device Identifier (UDI): 07332940007928 Batch Number: 1001425217 Lot Number: 15407 Expiration Date: 2025-Apr-13
الممثل المعتمد
Beckman Coulter Saudi Arabia Co Ltd
سبب المشكلة
Some of the above product customers have experienced a higher number of E5007 Probe Check Too Low errors than would typically be expected when using these tests and their intended use specimen types. E5007 yields a non-determinate result (Error).
الإجراء التصحيحي
If you experience an E5007 error when using a cartridge, repeat testing on another cartridge. If another E5007 error occurs, or if you have been experiencing intermittent E5007 errors on tests from these lots, Cepheid will replace any remaining tests that you currently have in inventory from lots. If you are experiencing issues and you would like to request replacement product, please refer to the attachment for instructions, stop using, and then dispose of any remaining tests from the applicable lots that are in your inventory.
المرفقات
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