SFDA National Center for Medical Devices Reporting

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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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NCMDR Recall

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Reference Number:	mdprc 010 05 18 000
Date submitted:	5/1/2018

Manufacturer:	bioMerieux Inc
Device Type:	VITEK MS
Description:	Bacterial and fungal identification system
Medical Device Identifier:	VITEK MS instrument ref. 410895, 412550, 410710, 413264 Lot/Serial : ALL
Reason of Field Safety Corrective Action:	It has been reported from the field and seen in production that the SAC door can occasionally stick open when operated. It has also been reported that during the annual preventative maintenance, the SAC door hinge shoulder bolt can seize in the hinge block when the door springs are replaced.
Remedy Action:	A solution to modify and improve the door assembly has been designed and validated by KRATOS. The modification involves the insertion of a plastic flanged bushing into the hinge.
Athorized Representative/Importer/Distributor:	Al-Jeel Medical & Trading Co. LTD
Report Source:	NCMDR
Source Ref. Number:	939DF66AF9389
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	bioMerieux Inc..pdf

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