X
OK Your changes have been successfully saved
SFDA Home Page
Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
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
Manufacturer:Abbott
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