[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 correspo
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| 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. |
|---|---|
| Brand / manufacturer | Roche Molecular Systems, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0486-2013 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 16 July 2012 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Roche Molecular Systems, Inc.
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.