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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 077 07 18 000
Date submitted: 7/12/2018
Device Type:Alinity ci‐series System Control Module (SCM)
Description:Analyzers, Laboratory, Clinical Chemistry/Immunoassay
Medical Device Identifier:List Number (LN): 03R70‐01
Reason of Field Safety Corrective Action:Abbott has identified the following issues with the Alinity ci‐series which may present a potential performance issue in Alinity ci‐series Software version 2.10. Abbott is releasing Alinity ci‐series Software version 2.50 to correct these issues (see details in Appendix A).
1. Removing racks during the Maintenance state is not detected by the system. Issues with orders may occur when reloading a rack with samples and returning to Running state.
2. Orders created using more than one of the i‐series, c‐series, or Calculated options to select assays will only include the assays selected in the last filtered view, if the order is saved prior to returning to the All option.
3. Enabling an assay when the processing module is in the Running or Processing status causes the assay to be re‐installed.
4. A sample with 270 test orders remained in the Scheduled status and would not process.
5. Some maintenance and diagnostic procedures can appear to have completed successfully when there was insufficient inventory.
Remedy Action:Your Abbott representative will be scheduling a mandatory upgrade of your Alinity ci-series SCM to Software version 2.50 to resolve each of these issues. Refer to Appendix A (See attached FSN) for necessary actions required until software version 2.50 can be installed.
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv
Report Source:NCMDR
Source Ref. Number:096EF15C93257
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott.pdf