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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 052 12 12 000
Date submitted: 12/10/2012
Manufacturer:DiaMed AG (a Division of Bio-Rad)
Device Type:Data Management and Result Interpretation Software, IH-Com kit Fullversion
Description:Data Management and Result Interpretation Software
Medical Device Identifier: Product REF: 009000 Software versions: 03.0.43/03.0.52/03.0.59
Reason of Field Safety Corrective Action: In case of not interpretable results in the anti-AB well (AB03) of ID-Cards intended for ABO forward grouping, the IH-Com software doesn't include the reaction of this well (result code -30) when sending the results to the laboratory Host.
Remedy Action: This issue will be permanently corrected through the deployment of the new IH-Com software version. In the meantime to exclude the residual risk, we advise you to immediately implement the attached protective measures:
Athorized Representative/Importer/Distributor:Al Nahir Trading Co, Riyadh, (01) 4770444
Report Source:NCMDR
Source Ref. Number:4A2A06648C16A
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: DiaMed AG (a Division of Bio-Rad).pdf