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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 138 05 16 001
Date submitted: 5/29/2016
Device Type:ACCELERATOR Automated Processing System (APS)
Description:Centrifuge Module
Medical Device Identifier:List Number : 07L02


NCMDR update code :

ACCELERATOR a3600 Centrifuge Module
List Number : 06P37
Reason of Field Safety Corrective Action:Abbott Diagnostics has been notified that the manufacturer of the centrifuge recommends an immediate reduction in the operating speed of the centrifuge not to exceed a maximum of 3500 RPMs. Material changes may have had an impact on the bucket strength, which could lead to the bucket becoming dislodged in the centrifuge
Remedy Action:-Immediately reduce the maximum RPMs to 3500.
-Visually inspect your centrifuge buckets for cracks If any cracks are identified OR if the “useable until” date has expired, immediately stop using the centrifuge.
-Contact Customer Service to arrange for replacement buckets.
-Continue to perform Weekly Maintenance per the ACCELERATOR APS Operations Manual (580799015.0, September 2014).
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv
Report Source:NCMDR
Source Ref. Number:E1021A240C12D
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott Diagnostics.pdf