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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 153 06 12 000
Date submitted: 6/27/2012
Manufacturer:Siemens Healthcare Diagnostics
Device Type:EasyLink™ Informatics System, Sysmex® CA Series Analyzer
Description:Informatics System
Medical Device Identifier: Version 5.0, all SP versions CA-7000 or CA-1500 1000034805
Reason of Field Safety Corrective Action: Siemens Healthcare Diagnostics has discovered that when using a Sysmex® CA-7000 or CA-1500 coagulation analyzer with the EasyLink system, there is a potential for the EasyLink system to display and transmit to the LIS an incorrect result following the EasyLink systems application of the configured result number format
Remedy Action: Siemens recommends that the result number format configured on the Sysmex® CA-7000 or CA-1500 coagulation analyzers are set to match the configuration settings on the attached file. Please note that using configurations different than those included with this letter could result in the reporting of incorrect results.
Athorized Representative/Importer/Distributor:Abdulrauf Ibrahim Batterjee & Bros. Company, Jeddah, (02) 6602933
Report Source:NCAR
Source Ref. Number:UK-2012-06-19-116
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Siemens Healthcare Diagnostics.pdf