تسجيل الدخول
تسجيل جديد
الجمعة - محرم 2, 1447
عن تيقظ
بحث عن منتج
تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-02-12-24-697
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Atellica IM Analyzer
الأجهزة المتأثرة
Assay: Atellica IM Total Triiodothyronine Test Code: T3 Siemens Material Number/ Unique Device Identification: - 10995679 / 00630414599922 - 10995678 / 00630414599915 Kit Lot Number: 23047272, 28261272, 23046272, 78082274, 78083274, 78084274, 78145274, and higher
الممثل المعتمد
Abdulrehman Algosaibi GTC
سبب المشكلة
The affected lots do not meet the Pack Calibration Interval of 21 days as stated in the Instructions for Use.
الإجراء التصحيحي
As a temporary mitigation for the above issue, perform the actions provided below to reduce the Pack Calibration Interval from 21 days to 3 days. • Remove any open T3 reagent packs onboard the system. • Navigate to IM Test Definition. • Select the ‘T3’ assay from the list. • Select the ‘Calibration’ option. • Change the Pack Calibration Interval frequency from 21 days to 3 days and save. • Load one new T3 reagent pack onto the system. • Perform Lot Calibration and ensure QC is in range. Note: Load and run only one T3 reagent pack on the system at a time. With every fresh T3 reagent pack that is loaded onto the system, ensure QC is in range. Recalibrate if QC results do not meet acceptance ranges. Manufacturer Action: Instructions.
المرفقات
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