The MagNA Pure LC — Class II medical device recall Z-0485-2013
Terminated recall by Roche Molecular Systems, Inc., reported 2012-12-19, distributed nationwide. Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
| Recall number | Z-0485-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Molecular Systems, Inc., Branchburg, NJ, United States |
| Recall initiated | 2012-07-16 |
| Classified | 2012-12-07 |
| Reported by FDA | 2012-12-19 |
| Terminated | 2015-07-22 |
| Distributed | Nationwide (US) |
| Quantity | 816 units |
| Reason classes | software |
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 for recall
Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0485-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.