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 054 08 18 000
Date submitted: 8/14/2018
Manufacturer:Abbott
Device Type:Alinity ci‐series System Control Module (SCM).
Description:IVD
Medical Device Identifier:List Number (LN): 03R70‐01
Software Version 2.5.1 (List Number 04V20‐05)
Reason of Field Safety Corrective Action:Alinity ci‐series Software Version 2.5.0 (List Number 04V20‐03) contained changes to how the Alinity i processing module handled process path movement issues. After installing this new software version, customers have reported an increase in the occurrence of message code 5752: "Process path move error on (0) lane. 0 = Process path lane." When this message code occurs, all tests are sent to exception. Recovery from the error requires the operator to initiate or resume sample processing on the Alinity i processing module. The increase in the message code 5752 is due to a less effective auto‐recovery procedure contained in software version 2.5.0.
Remedy Action:Your Abbott representative will be contacting you to schedule the installation of Software version 2.5.1.
Please complete and return the attached customer reply form.
Please retain this letter for your laboratory records.
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv
Report Source:NCMDR
Source Ref. Number:46F71E16311A2
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott.pdf