تسجيل الدخول
تسجيل جديد
السبت - جمادى الآخرة 8, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
عن تيقظ
بحث عن منتج
تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-12-05-25-888
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Liquid Urine Control – Level 2 and Assayed Urine Control – Level 3
الأجهزة المتأثرة
Device Name (Catalogue Number, UDI, Batch / Lot number, Expiry Date, Manufacturing Date): Liquid Urine Control – Level 2 (UC5074, 05055273207569, 1337UC, 28th Feb 2026, 18th April 2024) Assayed Urine Control – Level 3 (AU2353, 05055273200546, 1358UC, 28th Aug 2028, 20th Feb 2025)
الممثل المعتمد
Bio Standards LLC
سبب المشكلة
It has been confirmed by Randox there has been a transcription error in the Instructions for Use (IFU) for the affected products, and some targets and ranges have been listed incorrectly too.
الإجراء التصحيحي
Please refer to Table 1 in the attachment for the correct targets and ranges for the Method section and Table 2 in the attachment also for ‘Siemens Atellica Solution’ and ‘Siemens Dimension RxL/Max/Xpand/EXL’ sections. For Assayed Urine Control Level 3 lot 1358UC the targets and ranges for the analyte Creatinine, in units mmol/l, have been listed incorrectly in the ‘Method’ section on the IFU. Please refer to Table 3 in the attachment too for the correct targets and ranges. Download corrected IFU from Smartdocs.com and discard of previous copies. Manufacturer Action: Instructions and correction.
المرفقات
عودة للقائمة
