X
OK Your changes have been successfully saved
SFDA Home Page
Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 067 10 17 000
Date submitted: 10/18/2017
Manufacturer:Bio Rad
Device Type:Salmonella Antiserum
Description:IVD, used for serological identification of Salmonella cultures
Medical Device Identifier:Multiple lot numbers of the affected device are provided in the attached FSN.
Reason of Field Safety Corrective Action:There is a risk of nonspecific agglutination between 30 seconds and 1 minute when using the antisera mentioned above with Salmonella for which the antigenic formula does not include the corresponding flagellar H antigen. Performance degradation was verified on collection strains of known antigenic formula.
Remedy Action:Bio Rad ask you to carefully analyze your results. For further information, please contact your usual Bio-Rad representative.
Athorized Representative/Importer/Distributor:Al-Jeel Medical & Trading Co. LTD
Report Source:NCMDR
Source Ref. Number:E40C4A6F191C2
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Bio-Rad.pdf