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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 103 12 18 000
Date submitted: 12/24/2018
Device Type:Alinity i Processing Module.
Medical Device Identifier:List Number: 03R65‐01

Serial Number: Ai01001 to Ai01455, Ai01457, Ai01459
Reason of Field Safety Corrective Action:Abbott has identified an issue with the Alinity i Gear Pump Assembly (part number A‐30108552‐01) resulting in foaming/bubbling out of the bottle reservoir for Concentrated Wash Buffer and an unexpected amount of dried residue of buffer.

The foaming/bubbling is a result of an improper calibration of the pump’s operating speed.
Remedy Action:Please continue to follow the instructions provided in the Alinity ci‐series Operations Manual when accessing the bulk solution reservoir area to prevent skin contact.

Your Abbott representative will be contacting you to schedule the replacement of the Gear Pump Assembly A‐30108552‐01 in the Concentrated Wash Buffer position with a properly calibrated pump part number A‐30111949‐01.

Please complete and return the attached Customer Reply form.

If you have forwarded the product listed above to other laboratories, please inform them of this Product Correction and provide to them a copy of this letter.

Please retain this letter for your laboratory records.
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv
Report Source:NCMDR
Source Ref. Number:FD5FDF187F2D2
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott.pdf