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Roche Molecular Systems, Inc. recalls The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation of nucleic
Recalled December 19, 2012 · FDA recall Z-0486-2013 · Roche Molecular Systems
Hazard
Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. · FDA Class II
Units
13 units
Sold at
Nationwide Distribution
Description
Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Product
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.
Manufacturer(s)
Roche Molecular Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →