Recall Z-0485-2013— Roche Molecular Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Roche Molecular Systems, Inc., initiated 2012-07-16, terminated 2015-07-22. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue..
- Recalling firm
- Roche Molecular Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-07-16
- Terminated
- 2015-07-22
- Firm location
- Branchburg, NJ, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.