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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 087 11 17 000
Date submitted: 11/26/2017
Manufacturer:Thermo Fisher Scientific Inc.
Device Type:Thermo Scientific Remel Shigella sonnei (Phases 1&2) Agglutinating Serum
Description:Shigella sonnei (Phases 1&2) Agglutinating Serum
Medical Device Identifier:Product code: R30164201 Bottle lot No. Carton lot No 1465528 : 1465529 1847290 : 2118879, 2194099, 2173683, 2161363, 1984639, 2149414, 2135578 1738565 : 1738564, 1971308, 1957305, 1947930, 1847285, 1738566
Reason of Field Safety Corrective Action:An internal technical investigation has determined that Thermo Scientific™ Remel™ Shigella sonnei (Phases 1&2) Agglutinating Serum (lots listed above) may fail to agglutinate within the specified minimum reaction time when tested with Shigella sonnei phase 2 bacteria. Continued use of these lots may result in a failure to correctly identify isolates as Shigella sonnei phase 2.
Remedy Action:Accordingly, in keeping with our Quality Policy, we request that you destroy any remaining inventory of the lots listed above. Requirement for review of reported test results should be determined by the appropriate technical expert.
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv
Report Source:NCMDR
Source Ref. Number:0A13B8404615B
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Thermo Scientific Remel.pdf