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Roche Molecular Systems, Inc. recalls LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection and/or quantification
Recalled December 19, 2012 · FDA recall Z-0488-2013 · Roche Molecular Systems
Hazard
Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. · FDA Class II
Units
1,213 units
Sold at
Nationwide Distribution
Description
Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
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(s)
Roche Molecular Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →