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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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EN
SA-21-07-24-520
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Access HBc Ab Reagent
الأجهزة المتأثرة
Ref: 34240 Lot: 494327 Expiry Date: 12-Aug-2025
الممثل المعتمد
Beckman Coulter Saudi Arabia Co Ltd
سبب المشكلة
The affected lot may contain an unusual amount of paramagnetic particle (PMP) clumping at the top of Well 0.
الإجراء التصحيحي
Before inversion, visually inspect all reagent packs from Access HBc Ab reagent kit lot number listed in the table above. For any Access HBc Ab reagent pack where PMP clumping is observed at the top of Well 0: o Discontinue using the reagent pack and discard following your local laboratory protocols. o Contact your local Beckman Coulter representative to order replacement product for any affected reagent packs. For any Access HBc Ab reagent pack where PMP clumping is not observed at the top of Well 0: o Continue using the reagent pack. o As per the Access HBc Ab reagent Instructions for Use (IFU), mix contents of new (unpunctured) reagent packs by gently inverting pack several times before loading on the instrument. Ensure all Access HBc Ab reagent packs are stored in an upright position. Share the content of this letter with your laboratory and/or Medical Director regarding the need to review previous patient test results.
المرفقات
عودة للقائمة
