Roche LightCycler 1.2 Diagnostic Software Recalled for Device-Associated Issue
Roche Molecular Systems is recalling LightCycler 1.2 software due to a device-associated diagnostic software issue. The recall covers 3,772 units distributed nationwide.
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, 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 the LightCycler 1.2 (software version 3.5), a Rapid PCR analyzer with real-time detection and quantification capabilities. The recall involves 3,772 units that were distributed nationwide.
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 potential impact on diagnostic results, or any reported injuries or illnesses.
Users of the LightCycler 1.2 software should contact Roche Molecular Systems for further instructions on how to address the software issue. No specific corrective actions, such as software updates or device replacements, are detailed in the provided source text.
The recalled product
- Product
- LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve analysis with corresponding assays.
- Manufacturer
- Roche Molecular Systems, Inc.
- Hazard
- Affected units
- 3,772
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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