PlainRecalls
FDA Devices Moderate Class II Terminated

The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument for automated isolation of nucleic acids in various types of biological materials.

Reported: December 19, 2012 Initiated: July 16, 2012 #Z-0485-2013

Product Description

The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument for automated isolation of nucleic acids in various types of biological materials.

Reason for Recall

Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.

Details

Units Affected
816 units
Distribution
Nationwide Distribution
Location
Branchburg, NJ

Frequently Asked Questions

What product was recalled?
The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument for automated isolation of nucleic acids in various types of biological materials.. Recalled by Roche Molecular Systems, Inc.. Units affected: 816 units.
Why was this product recalled?
Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 19, 2012. Severity: Moderate. Recall number: Z-0485-2013.