SFDA National Center for Medical Devices Reporting

X

Your changes have been successfully saved

Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
Home Published FSNs/Recalls About NCMDR Contact Us FAQ Login

NCMDR Recall

Back

Reference Number:	mdprc 112 04 12 000
Date submitted:	4/28/2012

Manufacturer:	DiaMed AG (a Division of Bio-Rad)
Device Type:	IVDs, blood transfusion instrumentation, IH-Com software Full kit version
Description:	IVDs, blood transfusion instrumentation
Medical Device Identifier:	Product REF: 009000; IH-Com software versions: 03.0.43, 03.0.52, 03.0.59
Reason of Field Safety Corrective Action:	If different patients (e.g. A & B) having the same first name, last name and date of birth are tested in the system, the data management system IH-Com could merge the files of these patients even if patients ID are used.
Remedy Action:	This issue will be permanently corrected in the next IH-Com software version (currently in validation). In the meantime to exclude the residual risk, DiaMed advise you to implement the following immediate protective measures (see attached)
Athorized Representative/Importer/Distributor:	Al Nahir Trading Co, Riyadh, (01) 4770444
Report Source:	NCMDR
Source Ref. Number:	BA364490B0274
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Dia Med.pdf

View History