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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 103 06 18 000
Date submitted: 6/27/2018
Manufacturer:Abbott
Device Type:Alinity s System
Description:Analyzers, Laboratory
Medical Device Identifier:List Number (LN): 06P16‐01
Reason of Field Safety Corrective Action:Abbott has developed Alinity s System software V2.0 (LN 04U76‐07) to address known issues and enhance the overall Alinity s System (LN 06P16‐01).
Remedy Action:Your Abbott representative will be scheduling mandatory upgrades of your Alinity s System to install Alinity s System software V2.0 in the upcoming weeks. In the interim refer to Appendix A for necessary actions required until software V2.0 can be installed.
In addition to correcting these software issues, the software update includes a number of changes intended to improve performance and reliability.
Follow your laboratory procedures and please retain this letter for your laboratory records.
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv
Report Source:NCMDR
Source Ref. Number:3C39DB36261AC
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott.pdf