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مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-09-12-24-701
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
VITROS Chemistry Products DGXN Slides
الأجهزة المتأثرة
Catalog Number (Unique Device Identifier): 834 3386 (10758750004782) Affected Coatings: All current and expired coatings.
الممثل المعتمد
Samir Trading and Marketing CJSC
سبب المشكلة
VITROS® Chemistry Products DGXN Slides may generate negatively biased results due to hemoglobin interference at a concentration lower than what is currently listed in the Instructions For Use (IFU) at 300 mg/dL.
الإجراء التصحيحي
• For customers who have VITROS 5,1 FS/4600/5600/XT 3400/XT 7600 Systems: Load ADD DRV 6308 upon receipt. • For customers who have VITROS 250/350 Systems: Please be aware of the lowering of the Interferent Concentration limit from 300 mg/dL to 100 mg/dL at a digoxin concentration of 2.0 ng/mL (2.6 nmol/L). • Save this notification with your User Documentation or post this notification by each VITROS 250/350/5,1 FS/4600/5600/XT 3400/XT 7600 System in your laboratory until the issue has been resolved, refer to the attachment for more information. Manufacturer Action: Instructions and Correction.
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