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تسجيل جديد
الجمعة - محرم 2, 1447
عن تيقظ
بحث عن منتج
تقديم بلاغ
أسئلة شائعة
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EN
SA-09-09-24-586
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Atellica IM Analyzer
الأجهزة المتأثرة
Assay (Siemens Material Number/Unique Device Identification, Kit Lot Number): Atellica IM Anti- Thyroid Peroxidase (100 Test) (10995466 / 00630414597935, 26098336) Atellica IM Anti- Thyroid Peroxidase (500 Test) (10995467 / 00630414587837, 26099336) Test Code: aTPO Manufacturing Date: 10-Dec-2023 Expiration Date: 10-Dec-2024
الممثل المعتمد
ABDULREHMAN AL GOSAIBI GTB
سبب المشكلة
There is a potential for a positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed above when compared to alternate lots on the Atellica IM analyzer.
الإجراء التصحيحي
• Discontinue use of and discard the kit lots listed above, refer to the attachment for more information. • Please review the attachment with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. • Please retain the attachment with your laboratory records.
المرفقات
عودة للقائمة
