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الجمعة - رجب 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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EN
SA-14-01-26-1210
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
ACL Elite/ ACL Elite Pro
الأجهزة المتأثرة
HemosIL Silica Clotting Time, Part No. 0020004800, All Lot. Please refer to the Appendix A in the attachment. Impacted Instruments: Instruments (Part Number, UDI): ACL Elite (0000880311, 08426950453017) ACL Elite (Refurbished) (0000880311R, 08426950965572) ACL Elite Pro (0001000311, 08426950451570) ACL Elite Pro (Refurbished) (0001000311R, 08426950453482)
الممثل المعتمد
ABDULLA FOUAD HOLDING COMPANY
سبب المشكلة
It has been determined by werfen that HemosIL Silica Clotting Time does not meet the labeled on-board instrument stability claim of 5 days at 15°C when used on ACL Elite and ACL Elite Pro instrument platforms. As a result, there is potential for falsely prolonged Silica Clotting Time (SCT) results when HemosIL Silica Clotting Time reagents remain on-board these instruments during testing. This erroneous prolongation may cause an increased normalized SCT screen-to-confirm ratio, potentially leading to a false-positive lupus anticoagulant (LAC) interpretation.
الإجراء التصحيحي
Discontinue use of HemosIL Silica Clotting Time (Part No. 0020004800) on the ACL Elite and ACL Elite Pro. Contact Werfen representative to schedule the Mandatory Library 02.06.00 upgrade for your instruments. Post the attachment on each of your ACL Elite and ACL Elite Pro instruments. Manufacturer Action: Instructions & Correction.
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