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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 012 10 11 000
Date submitted: 10/8/2011
Manufacturer:Abbott
Device Type:Reagent, Clinical Chemistry Urea Nitrogen
Description:Chemistry, Reagent
Medical Device Identifier:List Number: 7D75-31, Lot Number: 97668UN11. List Number: 7D75-21, Lot Number: 97642UN11.
Reason of Field Safety Corrective Action:Abbott Diagnostics is recalling Clinical Chemistry Urea Nitrogen reagent due to particulate matter in some reagent cartridges.
Remedy Action:Discontinue use and destroy any remaining inventory. Order alternative lots of Clinical Chemistry Urea Nitrogen.
Athorized Representative/Importer/Distributor:Abbott Diagnostics Division , Jeddah , (02) 6511077
Report Source:NCMDR
Source Ref. Number:C3F0ED8D2034D
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott.pdf