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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 087 11 17 000
Thermo Fisher Scientific Inc.
Thermo Scientific Remel Shigella sonnei (Phases 1&2) Agglutinating Serum
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.
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.
Medical supplies & Services Co.Ltd Mediserv
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Thermo Scientific Remel.pdf
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.