تسجيل الدخول
تسجيل جديد
السبت - جمادى الآخرة 27, 1446
عن تيقظ
بحث عن منتج
تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-28-07-24-536
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
IRISpec CA/CB/CC
الأجهزة المتأثرة
REF (LOT): 800-7211 (432-24 and higher) 800-7702 (432-24 and higher)
الممثل المعتمد
Beckman Coulter Saudi Arabia Co Ltd
سبب المشكلة
Potential of intermittent IRISpec CB glucose control failure, resulting in false positive results when used in conjunction with iChemVELOCITY Urine Chemistry Strips PNs 800-7204 and 800- 7212.
الإجراء التصحيحي
Beckman Coulter has updated its control ranges to move the negative Glucose control from IRISpec CB to IRISpec CC. Customers are to update the CB and CC control ranges for Glucose, instructions on how to complete this are provided in the attachment. The updated Glucose ranges supersede the ranges listed in the IRISpec CB control Instructions for Use (IFU) PN C36362.AC, C36361.AC and the assay sheet C39722.AC and C39721.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
