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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 017 10 11 000
Abbott Laboratories Inc
Laboratory, Architect, Cyclosporine assay
Medical Device Identifier:
ARCHITECT Cyclosporine List Number 1L75 (all in-date lots)
Reason of Field Safety Corrective Action:
Abbott has confirmed that the ARCHITECT Cyclosporine assay has the potential to generate falsely elevated or depressed results with patient samples due to precision exceeding the Package Insert claim of <15% total CV. Calibrators and Controls also have the potential to be impacted by the assay imprecision.
Company provided action to be done by user. (Attached)
Medical supplies & Services Co.Ltd Mediserv. Riyadh (01) 4780555
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Abbott Laboratories Inc.pdf
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.