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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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Reference Number:	mdprc 097 02 18 000
Date submitted:	2/19/2018

Manufacturer:	Roche Diagnostics
Device Type:	Hematoxylin II and Horseradish Peroxidase reagents
Description:	In vitro diagnostic devices
Medical Device Identifier:	Product Name : GMMI OptiView DAB IHC Detection Kit : 06396500001 ultraView DAB IHC Detection Kit : 05269806001 iView DAB IHC Detection Kit : 05266157001 ultraView SISH Detection Kit : 05271967001 ultraView SISH DNP Detection Kit US : 05572037001 CINtec PLUS Cytology Kit (CE-IVD) : 06889565001 CINtec PLUS Cytology Kit (Canada/Japan) : 06889549001 OptiView Amplification Kit : 06396518001 OptiView Amplification Kit (250 Test) : 06718663001 Hematoxylin II : 05277965001 ultraView SISH DNP Detection Kit : 05907136001 NEXES VEN IVIEW DAB DET KT JPN-US EXPORT : 05266084001 CINtec PLUS Cytology Kit (US-Export) : 06889549001 Multiple Lot numbers of the affected products are provided in attached FSN.
Reason of Field Safety Corrective Action:	Ventana Medical Systems, Inc. (Ventana, also known as Roche Tissue Diagnostics (RTD) outside the US) has received increased customer complaints reporting leaking and sticking reagent dispensers. These reports are currently focused on horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II. Ventana has identified the cause of the issue, and is working to correct it. Additionally, Ventana has mandated specific requirements for same slide controls, detailed below, for customers with affected product in inventory.
Remedy Action:	All affected product has been placed on hold. Ventana has reworked all product in its inventory and is in the process of manufacturing new lots for distribution and replacement of customer affected kits. Customers will be notified when corrected product is available. Affected kits may continue to be used by customers until corrected product is available, however Ventana is mandating that the affected IHC detection kits (iView, ultraView, OptiView) must only be used in conjunction with same-slide controls.
Athorized Representative/Importer/Distributor:	Al-Jeel Medical & Trading Co. LTD
Report Source:	NCMDR
Source Ref. Number:	A6B96B5514233
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Roche Diagnostics.pdf

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