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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 090 11 11 000
Date submitted: 11/27/2011
Manufacturer:Abbott
Device Type:Reagents, Tobramycin Calibrators
Description:IVD, Reagents
Medical Device Identifier:List Number 7F93-01. Calibrator Lot Number: 59281991, 59359468, 59390335, 59511648
Reason of Field Safety Corrective Action:The company has confirmed an average shift in results of approximately -35% for commercial controls and -22% for College of American Pathologists (CAP) samples when using Tobramycin Calibrator.
Remedy Action:Immediately discontinue use and destroy any remaining inventory of the products. Evaluate your quality controls. Order alternate lots of Tobramycin Calibrators (LN 7F93-01).
Athorized Representative/Importer/Distributor:Abbott Diagnostics Division, Riyadh (01) 2917222
Report Source:NCMDR
Source Ref. Number:4601F24CF927E
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott.pdf