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.
Reported: December 19, 2012 Initiated: July 16, 2012 #Z-0486-2013
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.
Details
- Recalling Firm
- Roche Molecular Systems, Inc.
- Units Affected
- 13 units
- Distribution
- Nationwide Distribution
- Location
- Branchburg, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Roche Molecular Systems, Inc.. Units affected: 13 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-0486-2013.
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