FDAFDA · Alimentos y medicamentos·N.º oficial Z-0976-2017
MagSIL (NucliSENS easyMAG Magnetic Silica), Product Usage: The NucliSENS¿ easyMAG¿ system is an in vitro diagnostic medical device and is intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens.
Publicado el 25 de enero de 2017 · Inicio del retiro: 23 de noviembre de 2016
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
A drift of the performance with the BK test (BK virus, worst case application) was observed for some silica batches of Magnetic Silica (MagSil). This is the same issue as in recall Z-2342-2016.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- BioMerieux SA
- Distribuidor
- Worldwide distribution. US Nationwide; BioMerieux Subsidiaries in: Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech republic, Germany, Spain, France United Kingdom, Greece, China, Hungary, India, Italy, Japan, South Korea, Netherlands, Poland, Portugal, Russia Fed., Sweden, Singapore, Thailand, Turkey, South Africa; Distributors in: Peru, Kenya, Morocco, Serbia, Romania, Uruguay, Latvia, Dutch Antilles, Israel, Georgia, Armenia, Malaysia, Belarus and Direct Customers in: Togo, Djibouti, Burkina Faso, Mongolia, Zimbabwe, Uganda and Iraq.
- Lote
- Reference number: 280133, Lot numbers: Z017KA1MS, Z017KB1MS, Z017LE1MS, Z017MA1MS, Z017NA1MS, Z017NB1MS, Z017NC1MS and Z017ND1MS.
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- France
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