FDA Device recall Z-0485-2013
The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument for automated isolation…
- FDA Device
- Class II
- terminated
- Published 2012-12-19
On 2012-12-19 the FDA classified a Class II recall of The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument for automated isolation… by Roche Molecular Systems, citing roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0485-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-16 |
| Published | 2012-12-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Roche Molecular Systems |
| Distribution | US |
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.
Identifiers
| code_info | Device-associated diagnostic software |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0485-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.