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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 055 09 11 000
Date submitted: 9/19/2011
Manufacturer:bioMerieux Inc
Device Type:IVD, Rapid testing
Description:IVD, kit, tests
Medical Device Identifier:Slidex Pneumo Kit 50 tests. Part number 58821, Lot number 1101103874, Expiration date 21‐03‐2012.
Reason of Field Safety Corrective Action:Customer complaints for activity problem.
Remedy Action:Immediately place all existing inventory of this lot on hold until further notice.
Athorized Representative/Importer/Distributor:Al-Jeel Medical & Trading Co. LTD, Riyadh, (01) 4041717
Report Source:NCMDR
Source Ref. Number:0338B87110174
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: bioMerieux Inc - FSN.pdf