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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 083 09 18 000
Date submitted: 9/19/2018
Device Type:Alinity i Processing Module
Description:Analyzers, Laboratory, Clinical Chemistry/Immunoassay
Medical Device Identifier:List Number: 03R65
Serial Number: Ai01001 to Ai01336
Reason of Field Safety Corrective Action:Abbott has identified an issue with the Alinity i Bulk Solution Dispense Pumps (part number A‐35001280‐01) resulting in pump failures. The issue is linked to the design of an internal seal within the pump that allows a small amount of leakage of bulk solution(s) that eventually results in the pump failure.
Remedy Action:Your Abbott representative will be contacting you to schedule the replacement of all bulk solution dispense pumps A‐35001280‐01 with a redesigned dispense pump A‐35001280‐02.
Please complete and return the attached Customer Reply form.
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv
Report Source:NCMDR
Source Ref. Number:4AB08BB1C52FB
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott.pdf