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[Recalled] 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. —

recall fda device united-states

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

ProductLightCycler 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.
Brand / manufacturerRoche Molecular Systems, Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0488-2013
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date16 July 2012

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Roche Molecular Systems, Inc.

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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