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الجمعة - شعبان 11, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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EN
SA-26-01-26-1236
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Xpert Carba-R
الأجهزة المتأثرة
UDI-DI: 07332940006518 Part Numbers: GXCARBARP-CE-10 Batch / Lot / Expiry: Batch 1001496782 – Lot 13804 – Exp. 2027-02-07 Batch 1001499584 – Lot 13902 – Exp. 2027-03-07 Batch 1001508863 – Lot 14007 – Exp. 2027-04-25 UDI-DI: 07322940001049 Part Numbers: GXCARBAR-CE-10 Batch 1001497813 – Lot 13703 – Exp. 2027-02-21
الممثل المعتمد
Beckman Coulter Saudi Arabia Co Ltd
سبب المشكلة
It has been identified by Cepheid through customer complaints that some sample reagent vials from batch 1001497130 contain incorrect volume of 8mL instead of the 5mL correct volume. This specific sample reagent batch has been used for the manufacturing of the Xpert Carba-R batches listed above.
الإجراء التصحيحي
It is recommended by Cepheid retesting all patients with negative results who were tested using swab samples from the affected lots. For customers holding current inventory of the affected product, Cepheid will replace any product from listed above. If you have any Xpert Carba-R listed above with sample reagent batch 1001497130, stop using the product, dispose of the remaining affected product. Manufacturer's action: Removal.
المرفقات
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