Roche MagNA Pure 96 System Software Recall
Roche Molecular Systems is recalling 13 MagNA Pure 96 Systems due to a device-associated diagnostic software issue.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, but the source text does not report any hospitalizations, injuries, or specific high-risk hazards, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Roche Molecular Systems, Inc. is recalling 13 units of the MagNA Pure 96 System (versions 1.0 and 2.0). This instrument is used for the automated isolation of nucleic acids in various types of biological materials. The recall is due to a device-associated diagnostic software issue.
The affected units were distributed nationwide. The source text does not specify the exact nature of the software defect, the potential impact on diagnostic results, or any reported injuries or illnesses. There are no corresponding assays associated with this general-purpose instrument.
Users of the MagNA Pure 96 System should contact Roche Molecular Systems, Inc. for further instructions regarding the software issue and the recall process.
The recalled product
- 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.
- Manufacturer
- Roche Molecular Systems, Inc.
- Hazard
- Affected units
- 13
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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