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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 167 02 12 000
IVD, AxSYM Free T4 Standard Calibrators and Controls
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.
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.
Abbott Diagnostics Division, Riyadh, (01) 2917222
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.