OK Your changes have been successfully saved
SFDA Home Page
Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 167 02 12 000
Date submitted: 2/25/2012
Device Type:IVD, AxSYM Free T4 Standard Calibrators and Controls
Description:IVD, Calibrators
Medical Device Identifier:AxSYM Free T4 Standard Calibrators, LN 7K51-01, Lot Number 96238JN00, Expiry 05 January 2012. AxSYM Free T4 Controls, LN 7K51-10, Lot Number 96197JN00, Expiry 22 January 2012.
Reason of Field Safety Corrective Action:Usage of either AxSYM Free T4 Standard Calibrator or Control n their own may have resulted in an observation of controls out of range. Using them both together may have resulted in a valid calibration and depressed patient results may have been observed.
Remedy Action:Abbott would like to advise you to be vigilant when performing comparative analysis of Free T4 results if you had obtained a successful calibration with AxSYM Free T4 Standard Calibrator lot 96238JN00 and AxSYM Free T4 Control lot 96197JN00 during the time period between 01 October 2011 and 05 January 2012.
Athorized Representative/Importer/Distributor:Abbott Diagnostics Division, Riyadh, (01) 2917222
Report Source:NCMDR
Source Ref. Number:CE623C61B227F
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott.pdf