Roche Recalls LightCycler 2.0 Instrument Due to Diagnostic Software Issue
Roche Molecular Systems is recalling 1,213 LightCycler 2.0 instruments 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, and the source text does not report any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Roche Molecular Systems, Inc. is recalling 1,213 units of the LightCycler 2.0 Instrument (software version 4.1). The device is a rapid PCR analyzer used for real-time detection and quantification of target nucleic acids, as well as post-PCR analysis.
The recall was initiated because the manufacturer became aware of a device-associated diagnostic software issue. The affected units were distributed nationwide.
Users of the LightCycler 2.0 Instrument should contact Roche Molecular Systems, Inc. for further instructions regarding the software issue.
The recalled product
- Product
- LightCycler 2.0 Instrument (software version 4.1) 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.
- Manufacturer
- Roche Molecular Systems, Inc.
- Hazard
- Affected units
- 1,213
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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