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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-14-05-25-889
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
ACL TOP FAMILY, ACL TOP FAMILY 50 Series, ACL TOP FAMILY 70 Series
الأجهزة المتأثرة
The ACL TOP Family: includes the ACL TOP, ACL TOP CTS, ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS models. The ACL TOP Family 50 Series: includes the ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS models. The ACL TOP Family 70 Series: includes the ACL TOP 770, 770s, 770 LAS, 570 and 370 models.
الممثل المعتمد
Abdulla Fouad For Medical Supplies and Services Company
سبب المشكلة
A potential carryover issue that may cause elevated quality control and sample results when HemosIL Free Protein S (Part No. 0020002700) is tested in the same run as HemosIL D-Dimer HS 500 (Part No. 0020500100/0020500300).
الإجراء التصحيحي
Mandatory Parameters P-16.8.03 for the ACL TOP Family (SW 5.2.0), P-18.8.04 (SW 6.4.2) and P-18.6.07 (SW 6.5.3) for the ACL TOP Family 50 Series and P-22.1.02 (SW 1.4.0) or a higher version for the ACL TOP Family 70 Series contain the final mitigations to address the above carryover issue. Customers are requested to take the following actions: • Share the information in the attachment with your laboratory staff and update your internal procedures, as needed. • Post the attachment on all affected systems in your facility. • Contact your local Werfen Representative to install the Mandatory Test Parameters at your next service or applications visit. • Retain a copy of the attachment for your records. Manufacturer Action: Instructions and correction.
المرفقات
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