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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 062 04 18 000
Date submitted:	4/11/2018

Manufacturer:	Siemens Healthcare Diagnostics GmbH
Device Type:	ADVIA Chemistry Systems Urea Nitrogen (UN)
Description:	Urea Nitrogen
Medical Device Identifier:	Catalog number: 03040257 Siemens Material Number: 10309051 Lot Number: 408143 Exp Date 28/06/2018 Lot Number: 418290 Exp Date 28/06/2018
Reason of Field Safety Corrective Action:	Siemens Healthcare Diagnostics has confirmed that the Urea Nitrogen reagent kit lots listed in the table 1 above for use on ADVIA® 1800, 2400 and XPT Chemistry Systems demonstrate an increased incidence of Calibration Failures. Results cannot be generated by the system when calibration fails. If calibration passes, there is a potential for falsely elevated patient and quality control results.
Remedy Action:	Discontinue use of and discard the kit Lots listed above.
Athorized Representative/Importer/Distributor:	ABDULREHMAN AL GOSAIBI GTB
Report Source:	NCMDR
Source Ref. Number:	DDDCC8C9EB435
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Siemens Healthcare Diagnostics.pdf

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