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الجمعة - محرم 9, 1447
عن تيقظ
بحث عن منتج
تقديم بلاغ
أسئلة شائعة
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EN
SA-22-04-25-869
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Apolipoprotein (Apo) B Reagent
الأجهزة المتأثرة
REF: OSR6143 4x13 mL R1, 4x7 mL R2 Lot: 2631 Expiry Date: 01 Sep 2026
الممثل المعتمد
Beckman Coulter Saudi Arabia Co Ltd
سبب المشكلة
The affected product contains an incorrect target value of 166 mg/dL for the level 4 calibrator ODR3022, Lot 3000. The correct level 4 target value is 116 mg/dL. The value in g/L unit is correct.
الإجراء التصحيحي
If your laboratory is reporting Apo B results generated using the combination of reagent OSR6143, Lot 2631 and calibrator ODR3022, Lot 3000 in mg/dL units, a retrospective review of patient results greater than 77 mg/dL and less than 176 mg/dL is recommended. Beckman Coulter requests that each customer • Discard the value assignment sheet located within each kit of Apo B OSR6143 Lot 2631. • Download the updated VAS kit insert from the Beckman Coulter website by searching ‘LOSR6143_2631_ML.02. Beckman Coulter Diagnostics | Beckman Coulter • Ensure that the level 4 calibrator ODR3022, Lot 3000 target value used for calibration of Apo B OSR6143 Lot 2631 is 116 mg/dL and aligns with the corrected VAS. Manufacturer Action: Instructions and correction.
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