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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 110 03 12 000
Date submitted: 3/28/2012
Manufacturer:Siemens Healthcare Diagnostics
Device Type:VERSANT kPCR Molecular System
Description:Sample Preparation Module
Medical Device Identifier:REF 06691055, SMN 10283255. lot numbers 120571, 120572, 120573, 124628, 125967
Reason of Field Safety Corrective Action:The VERSANT® Molecular System Sample Preparation Module Heater/Shaker is Incompatible with recent lots of Deep Well Plates. This incompatibility can cause errors leading to premature termination of sample preparation runs and possible loss of sample.
Remedy Action:Contact your Siemens Customer Service Center to request a replacement at no charge for any DeepWell plates in the affected lots. DeepWell plates compatible with the VERSANT kPCR Molecular System must only be purchased through Siemens.
Athorized Representative/Importer/Distributor:Abdulrauf Ibrahim Batterjee & Bros. Company, Jeddah, (02) 6602933
Report Source:NCAR
Source Ref. Number:UK-2012-03-23-051
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Siemens Healthcare Diagnostics.pdf