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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 138 02 18 000
Date submitted: 2/27/2018
Device Type:Alinity hq Analyzer
Description:Analyzers, Laboratory, Clinical Chemistry/Immunoassay
Medical Device Identifier:List Number: 09P68‐01
Multiple serial numbers of the affected device are provided in the attached FSN.
Reason of Field Safety Corrective Action:Abbott Hematology has identified the following issue with Alinity hq Analyzer Software Version 1.0 and 2.0 when creating an open tube test order via the System Command Center (SCC) or through the Abbott Middleware System (AMS):

For open‐tube processing only, the system will default to “Unspecified” gender (instead of using male or female) and apply the limits that the user may have established for the “Unspecified” gender type. If the user did not establish limits, there will not be annotations/flags for the “Unspecified” gender type, as the system defaults to the factory‐established limits.
Remedy Action:- Your Abbott representative will begin scheduling software upgrades (Software Version 2.0.1) starting in February 2018.
- Until the software version 2.0.1 is installed on your system, review all open tube results as your established limits for the “unspecified” gender type may not meet your needs.
- If you have forwarded the product listed above to other laboratories, please inform them of this product information 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:9216EC3E32204
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott.pdf