Roche Data Station AMPLILINK Software Recalled for Device-Associated Issue
Roche Molecular Systems is recalling Data Station AMPLILINK software due to a device-associated diagnostic software issue. The software is used with various COBAS instruments for molecular diagnostics.
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 pathogens, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Roche Molecular Systems, Inc. is recalling Data Station AMPLILINK software, an instrument user interface and data management software. This software is used with COBAS AmpliPrep, COBAS TaqMan, COBAS TaqMan 48, COBAS AMPLICOR, and Cobas p 630 instruments for the sample preparation, amplification, and detection of PCR molecular diagnostic analytes.
The recall was initiated because the company became aware of a device-associated diagnostic software issue. The source text does not specify the exact nature of the software defect, the number of affected units, or the specific distribution locations, though the metadata indicates a nationwide distribution pattern.
Users of the affected software should contact Roche Molecular Systems for further instructions on how to address the issue. No specific consumer actions or health risks are detailed in the provided source text.
The recalled product
- Product
- Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS¿ AmpliPrep instrument, COBAS¿ TaqMan¿ analyzer, COBAS¿ TaqMan¿ 48 analyzer, COBAS¿ AMPLICOR¿ analyzer, and Cobas p 630 instrument for sample preparation, amplification and…
- Manufacturer
- Roche Molecular Systems, Inc.
- Hazard
- Affected units
- 884
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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