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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-08-05-25-884
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Urea reagent
الأجهزة المتأثرة
Catalogue Number: UR446 UDI: 05055273206920 Batch /Lot number: 606771 Expiry Date: 28 July 2025 Manufacturing: 09 August 2022
الممثل المعتمد
Bio Standards LLC
سبب المشكلة
The R1b Enzyme Reagent is no longer meeting its reconstituted stability claims of 4 weeks at +2 to +8°C or 2 days at +15 to +25°C. The calibration factor, QC’s and patient samples may decrease during repeat testing by up to -5% within 3hrs of reagent reconstitution.
الإجراء التصحيحي
Discontinue use of and discard any of the above immediately. Review results generated with the affected batches in line with the clinical profile of the patient. Discuss the contents of the attachment with your Medical Director to determine the appropriate course of action, including for any previously generated results. applicable follow your laboratories protocol regarding the need for reviewing previously reported patient results. Manufacturer action: Removal.
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