Recall Z-0486-2013— 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 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.. 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 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.
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.