Devices

Device Recall The NucliSENS easyMAG Magnetic Silica

Model / Serial
Reference number: 280133, Lot numbers: Z017KA1MS, Z017KB1MS, Z017LE1MS, Z017MA1MS, Z017NA1MS, Z017NB1MS, Z017NC1MS and Z017ND1MS.
Product Classification
Hematology and Pathology Devices
Device Class
1
Implanted device?
No
Distribution
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.
Product Description
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.
Manufacturer
BioMerieux SA
1 Event
- Recall of Device Recall The NucliSENS easyMAG Magnetic Silica

Manufacturer

BioMerieux SA

Manufacturer Address
BioMerieux SA, Chemin De L'Orme, Marcy L'Etoile France
Manufacturer Parent Company (2017)
Compagnie Merieux Alliance
Source
USFDA

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