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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 020 09 18 000
Date submitted:	9/9/2018

Manufacturer:	Abbott
Device Type:	Alinity s System
Description:	IVD
Medical Device Identifier:	List Number (LN) 06P16-01
Reason of Field Safety Corrective Action:	Alinity s System software V2.1.O is now available and will resolve the following issues that Abbott has identified. 1- When the Alinity s CMV IgG Qualitative assay is run as the last assay on a sample, the instrument may shut down. If the instrument does not shut down, the result is an insufficient wash of the probe. The insufficient wash may compromise the following sample aspirated with that probe, potentially causing a false reactive result for any of the assays run. 2-During sample processing, exceptions that have completed transmission to the Laboratory Information System (LIS) or middleware may continue to appear on the Alinity s Exception Details screen as Pending Transmission.
Remedy Action:	If you are running an Alinity s System software version prior to V2.0.0, the only action required is to update to software V2.1.O. Your Abbott representative will be scheduling mandatory upgrades of your Alinity s System to install Alinity s System software V 2.1.0.
Athorized Representative/Importer/Distributor:	Medical supplies & Services Co.Ltd Mediserv
Report Source:	NCMDR
Source Ref. Number:	AED0F37C1D30A
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Abbott-IVD-S.pdf

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