تسجيل الدخول
تسجيل جديد
الاثنين - رجب 23, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
عن تيقظ
بحث عن منتج
تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-28-07-24-537
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
IRISpec CA/CB/CC
الأجهزة المتأثرة
REF (LOT): 800-7702 (432-24 and higher)
الممثل المعتمد
Beckman Coulter Saudi Arabia Co Ltd
سبب المشكلة
Potential of intermittent IRISpec CB failures for Ketone on the iChemVELOCITY Urine Chemistry System (Instructions For Use PN 300-4449FH) and DxU 810c Iris Urine Chemistry System (Instructions For Use PN C49355AA). This issue affects IRISpec CB control lot numbers 432-24 and higher when analyzed with iChemVELOCITY Urine Chemistry Strips (PN 800-7204) lot numbers 7204661M and higher.
الإجراء التصحيحي
• Beckman Coulter has updated its Ketone control range for IRISpec CB. • Update the CB control ranges for Ketone as indicated in the attachment. For instructions, refer to Addendum A: “Updating the QC ranges for Ketone in the Analyzer”. • The Ketone ranges in the attachment supersede the ranges listed in the IRISpec CB control Instructions For Use (IFU) PN C36362.AC and the assay sheet C39722.AC. Use only the specifications in the attachment. • No retrospective review of QC or patient sample results is necessary. • It has been recommended by Beckman Coulter to post the attachment on/or near the analyzer.
المرفقات
عودة للقائمة
