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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 003 08 14 000
Date submitted: 8/1/2014
Device Type:Clinical Chemistry ICT Serum Calibrator
Description:Calibrator, IVD
Medical Device Identifier:Product Name : Clinical Chemistry ICT Serum Calibrator
List Number (LN) : 1E46-03
( Lot Number : Expiration Date )
( 21399UN13 : 5 AUG 2014 ) ( 67873UN13 : 12 NOV 2014 ) ( 74710UN13 : 8 DEC 2014 ) ( 82008UN13 : 14 JAN 2015 ) ( 88884UN13 : 4 FEB 2015 )
Reason of Field Safety Corrective Action:An Abbott investigation has identified that the ICT Serum Calibrator lots above may generate lower than expected Potassium Quality Control (QC) and patient results.
Remedy Action:- Place orders for replenishment product if needed through your normal ordering process.

- Follow your laboratory protocol regarding the need to review previously reported patient results.
Athorized Representative/Importer/Distributor:Abbott Diagnostics Division
Report Source:NCMDR
Source Ref. Number:4BD94AE1E3332
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott.pdf