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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 027 05 16 000
AB SCIEX Pte. Ltd
4500MD Mass Spectrometer
in vitro diagnostic
Medical Device Identifier:
QTRAP 4500MD (5031225) and Triple Quad 4500MD (5031225)
- See attached file for details -
Reason of Field Safety Corrective Action:
An issue has been identified with a small number of 4500MD LC/MS/MS Systems where under certain conditions, there is the possibility that a user will be presented with incorrect quantitative results.
Short term field corrective actions: •Affected units in Distribution Centers (Dallas and Netherlands) and Singapore manufacturing site have been quarantined. Units in Distribution Centers have been shipped to Singapore to conduct re-work.
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
AB SCIEX Pte. Ltd.pdf
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.