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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 069 02 18 000
Date submitted: 2/15/2018
Manufacturer:Abbott
Device Type:Alinity ci‐series System Control Module (SCM)
Description:Integrated Clinical Chemistry & Immunoassay System
Medical Device Identifier:03R70‐01
Reason of Field Safety Corrective Action:Abbott has identified the following issues with the Alinity ci‐series: 1. After a failure of the Reagent 2 (R2) pipettor, the software fails to send scheduled tests that were aspirated after the failure to Exceptions. 2. Results, reported in alternate result units, that are greater than the linearity incorrectly displays the numerical result value in the default units, for assays using the spline or logit‐4 data reduction method. 3. The host connection is disabled after 12 seconds when no order is received, even though the configured host query time‐out has not been exceeded. 4. An unexpected software shutdown can occur when printing the Assay Parameter Report when the Thousand/Decimal Separator number format is set to the Period and Comma option. Patient Impact Refer to Appendix A for details concerning any patient or safety impact related to the issues identified in Alinity ci‐series System Software version 2.00.
Remedy Action:Your Abbott representative will be scheduling mandatory upgrade of your Alinity ci-series SCM to resolve each of these issues in the upcoming weeks. Refer to Appendix A for necessary actions required until software version 2.10 can be installed.
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv
Report Source:NCMDR
Source Ref. Number:48F1836DE8311
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott.pdf