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تسجيل جديد
الجمعة - محرم 9, 1447
عن تيقظ
بحث عن منتج
تقديم بلاغ
أسئلة شائعة
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EN
SA-11-06-25-923
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
LIAISON Biotrin Parvovirus B19 IgM
الأجهزة المتأثرة
Model: 317010 (UDI-DI): 08056771101165 Lot: 129080 (expiry date: 14.12.2025)
الممثل المعتمد
Abdulla Fouad For Medical Supplies and Services Company
سبب المشكلة
Invalid calibrations or Positive Control out of range Low due to a drop in integral reactivity (signal, RLU). If after obtaining a valid calibration and a valid run by testing calibrators and Kit Controls right after integral shaking as per IFU, the kit is stored on-board of the instrument, there is a potential risk for obtaining False Negative results on daily routines.
الإجراء التصحيحي
- Stop to use the above lot. - Re-evaluate the negative results obtained with this lot of product, considering that, as reported in the IFU, a negative result for IgM antibodies to parvovirus B19 generally indicates that the patient has not been infected, but does not exclude the possibility of acute parvovirus B19 infection, refer to the attachment for more information. Manufacturer action: Instructions and removal.
المرفقات
عودة للقائمة
