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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall

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Reference Number:	mdprc 151 10 18 000
Date submitted:	10/31/2018

Manufacturer:	Siemens Healthcare Diagnostics
Device Type:	Atellica Sample Handler Prime (SH Prime)
Description:	IVD, Chemiluminescent immunoassay analyser IVD, automated
Medical Device Identifier:	Siemens Material Number (SMN): 11069001
Reason of Field Safety Corrective Action:	Siemens Healthcare Diagnostics is informing customers that the Atellica Solution software (SW) version 1.15 (SMN 11316446) does not support use of the following capillary collection containers loaded in the appropriate holder: -The green false-bottom capillary collection container holder – Holder Tube Capillary False Bottom (SMN 11069063). -The blue conical-bottom capillary collection container holder – Holder Tube Capillary (SMN 11069064).
Remedy Action:	Please contact your Siemens Customer Care Center or your local Siemens Technical Support representative to schedule a visit to upgrade your system to SW version 1.15SP1 if you require the system to be capable to run any
Athorized Representative/Importer/Distributor:	ABDULREHMAN AL GOSAIBI GTB
Report Source:	NCMDR
Source Ref. Number:	D45D5F611A20B
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Siemens Healthcare Diagnostics (Atellica).pdf

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