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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 164 03 16 000
AB SCIEX Pte. Ltd
Analyst MD Software
Medical Device Identifier:
Versions 1.6.1 and 1.6.2. Component of API 3200MD™ LC/MS/MS System, 3200MD QTRAP® LC/MS/MS System, Triple Quad™ 4500MD LC/MS/MS System, and QTRAP® 4500MD LC/MS/MS System
Recall ID: 3258–0095
Instrument Part Number (REF) : 5024501, 5024500, 5031257, 5031231
Reason of Field Safety Corrective Action:
An issue has been identified with Analyst MD software where under certain conditions a user can be presented with incorrect quantitative results.
In order to eliminate the potential for erroneous results, implement the following temporary steps:
1. If using the Formula column feature in the Analyst MD software’s Quantitation module for the processing and reporting of results, avoid deleting sample entries in the Results Tables.
2. If sample entries must be deleted from the Results Table, save, close, and reopen the results table prior to reporting values.\
If the device has been used for patient diagnosis using the Formula column feature in the Analyst MD software’s Quantitation module for the processing and reporting of results, the following additional actions should also be taken:
1. Open the original results table.
2. Compare the values in the Formula column to the original reported results.
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.