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مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-24-01-25-762
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Glucose Liquicolor
الأجهزة المتأثرة
Glucose Liquicolor Size (REF) 1- 1000 ml (10121) 2- 4 x 100 ml (10260) 3- 2 x 150 tests (10260300) 4- 6 x 210 tests (10260600) When applied on: HumaStar 100 (REF 16890) HumaStar 200 (REF 16895) HumaStar 300SR (REF 16930)
الممثل المعتمد
Abdullah A. Baghaffar
سبب المشكلة
It has been identified by HUMAN that, in rare cases, HumaStar 300SR in combination with the GLUCOSE liquicolor reagent may report falsely low glucose values for samples with concentrations above 450 mg/dL.
الإجراء التصحيحي
To fix these discrepancies, HUMAN has already developed an optimized setting, which should be installed immediately on all HumaStar 300SR instruments on which GLUCOSE liquicolor is measured. As an additional security measure, HUMAN has optimized the settings for HumaStar 100 and HumaStar 200 accordingly and recommends installing the new settings on all active systems. Please follow "Advice on action to be taken" in the attachment. Manufacturer action: instructions and correction
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