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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 027 05 16 000
Date submitted: 5/4/2016
Manufacturer:AB SCIEX Pte. Ltd
Device Type:4500MD Mass Spectrometer
Description: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.
Remedy Action: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.
Athorized Representative/Importer/Distributor:Bio Standards
Report Source:NCMDR
Source Ref. Number:2208595C02E1
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: AB SCIEX Pte. Ltd.pdf