FDA-Device2012-12-19Class II
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.
Roche Molecular Systems, Inc.
Hazard
Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Sold states
Nationwide Distribution
Affected count
3,772 units
Manufactured in
1080 Us Highway 202 S, N/A, Branchburg, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0487-2013Don't want to check this manually?
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