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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 006 06 13 000
Date submitted: 6/2/2013
Manufacturer:MAST International Ltd
Device Type:IVD,CIPROFLOXACIN 1ug CARTRIDGE DISCS
Description:Antibiotic Susceptibility
Medical Device Identifier:Cat:CIP1C / Lot No:316356
Reason of Field Safety Corrective Action:The investigation revealed that discs may be producing zones of inhibition that exceed the expected quality control
Remedy Action:It is recommended that use of this batch of discs within your laboratory is discontinued immediately whether or not any unexpected results have been noted
Athorized Representative/Importer/Distributor:Al Nahir Trading Co , Riyadh , (011) 4770444
Report Source:NCMDR
Source Ref. Number:4BBCA22C221F7
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Mast Group.pdf