Roche MagNA Pure LC Software Recall for Diagnostic Issue
Roche Molecular Systems is recalling 816 MagNA Pure LC instruments due to a device-associated diagnostic software issue.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a reasonable probability of temporary or medically reversible harm. As no specific injuries or illnesses are reported in the source text, and the issue is software-related, it fits the Moderate category for a precautionary recall.
Plain-English summary
Roche Molecular Systems, Inc. is recalling 816 units of the MagNA Pure LC (version 3.0) sample preparation instrument. The recall is due to a device-associated diagnostic software issue.
The affected instruments are used with the LightCycler instrument for the automated isolation of nucleic acids in various types of biological materials. The recall involves a nationwide distribution of the devices.
The source text does not specify the exact nature of the software defect or provide instructions for consumers on how to proceed. Users of the MagNA Pure LC (version 3.0) should contact Roche Molecular Systems, Inc. for further information regarding the software issue.
The recalled product
- 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.
- Manufacturer
- Roche Molecular Systems, Inc.
- Hazard
- Affected units
- 816
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Device-associated diagnostic software
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Roche Molecular Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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