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 018 06 15 000
Date submitted:	6/3/2015

Manufacturer:	AI DE DIAGNOSTIC CO., LTD.
Device Type:	First Step Plus
Description:	IVD, Pregnancy Test
Medical Device Identifier:	Item Number : 100-13 Lot Number : 130417C6
Reason of Field Safety Corrective Action:	Error in arabic instruction for use
Remedy Action:	-All affected products have been collected. -The wrong IFU have been replaced by the new updated IFU
Athorized Representative/Importer/Distributor:	Abdull Rahim Hazazy Trading & Contacting Est.,
Report Source:	NCMDR
Source Ref. Number:	6CED5904051BB
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	AI DE DIAGNOSTIC CO., LTD..pdf

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