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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 017 10 11 000
Date submitted: 10/11/2011
Manufacturer:Abbott Laboratories Inc
Device Type:Laboratory, Architect, Cyclosporine assay
Description:Assay, laboratory
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.
Remedy Action:Company provided action to be done by user. (Attached)
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv. Riyadh (01) 4780555
Report Source:NCMDR
Source Ref. Number:60C64241221CB
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott Laboratories Inc.pdf