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 033 11 14 000
Date submitted:	11/11/2014

Manufacturer:	Diamed GmbH
Device Type:	IH-1000
Description:	IVD, Fully automated
Medical Device Identifier:	Product name: IH-1000 Product REF: 001000 IH-1000 software version: all versions
Reason of Field Safety Corrective Action:	the IH-1000 software may lose the link sample/"test in progress". This loss might in the worst case lead to a mismatch between the test result and the sample.
Remedy Action:	This issue will be permanently corrected in the next IH-1000 software version. This version will be released by the end of Q1 2015. In the meantime, customers should immediately discontinue using the "emergency button" and should process ALL emergency samples exclusively on the urgent rack (red label).
Athorized Representative/Importer/Distributor:	Al Nahir Trading Co
Report Source:	NCMDR
Source Ref. Number:	BFAA4A2F7E260
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Bio Rad.pdf

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