FDA-Device2012-12-19Class II
The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation of nucleic acids in various types of biological materials. This is a general purpose instrument. There are no corresponding assays.
Roche Molecular Systems, Inc.
Hazard
Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Sold states
Nationwide Distribution
Affected count
13 units
Manufactured in
1080 Us Highway 202 S, N/A, Branchburg, NJ, United States
Products
The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation of nucleic acids in various types of biological materials. This is a general purpose instrument. There are no corresponding assays.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0486-2013Don't want to check this manually?
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