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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 155 06 12 000
Date submitted: 6/27/2012
Manufacturer:DiaMed GmbH
Device Type:Blood bank Analyzer, Techno TwinStation
Description:Analyzer, Blood
Medical Device Identifier:Product REF: 009895 software versions: All versions
Reason of Field Safety Corrective Action:Identified a trend of reactions weaker than expected when testing very weak samples on Techno TwinStation
Remedy Action:This issue will be permanently corrected with the new Techno TwinStation software Pack v.04.08.01, which is a mandatory update. As of now, this software pack is available and the deployment will be ensured by your field service engineers.
Athorized Representative/Importer/Distributor:Al Nahir Trading Co, Riyadh, (01) 4770444
Report Source:NCMDR
Source Ref. Number:A8D2313A6924E
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments