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.
Reported: December 19, 2012 Initiated: July 16, 2012 #Z-0488-2013
Product Description
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.
Reason for Recall
Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Details
- Recalling Firm
- Roche Molecular Systems, Inc.
- Units Affected
- 1,213 units
- Distribution
- Nationwide Distribution
- Location
- Branchburg, NJ
Frequently Asked Questions
What product was 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.. Recalled by Roche Molecular Systems, Inc.. Units affected: 1,213 units.
Why was this product recalled? ▼
Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 19, 2012. Severity: Moderate. Recall number: Z-0488-2013.
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