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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-13-04-25-853
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Liquid Assayed Specific Protein Control Level 1/2/3
الأجهزة المتأثرة
Liquid Assayed Specific Protein Control Level 1 Catalogue Numbers: PS2682 PS10221 UDI: 05055273204896 Batch / Lot numbers: 647LPC 686LPC 708LPC Liquid Assayed Specific Protein Control Level 2 Catalogue Numbers: PS2683 PS10222 UDI: 05055273204902 Batch / Lot numbers: 706LPC 709LPC Liquid Assayed Specific Protein Control Level 3 Catalogue Numbers: PS2684 PS10223 UDI: 05055273204919 Batch / Lot numbers: 707LPC 710LPC Please refer to the attachment for more information.
الممثل المعتمد
Bio Standards LLC
سبب المشكلة
The Rheumatoid Factor (RF) concentrations in Liquid Assayed Specific Protein Controls Level 1 Lots 647LPC and 686LPC are low below the measurement range of nephelometric methods on Siemens instruments.
الإجراء التصحيحي
Randox have updated the IFU’s and removed the associated targets and ranges of the affected Liquid Assayed Specific Protein Controls Level 1. Anti Streptolysin O (ASO) target and range values have been reassigned by Randox Laboratories in lot no’s 706LPC, 707LPC, 708LPC, 709LPC and 710LPC. Please refer to the table in the attachment for updated target values. Download corrected IFU from Smartdocs.com and discard of previous copies. Manufacturer action: Instructions and correction.
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