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 164 03 16 000
Date submitted: 3/24/2016
Manufacturer:AB SCIEX Pte. Ltd
Device Type:Analyst MD Software
Description: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.
Remedy Action: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.
Athorized Representative/Importer/Distributor:Bio Standards
Report Source:NCMDR
Source Ref. Number:8018B564F42A5
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: AB SCIEX.pdf