FDA Device recall Z-0487-2013
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)…
- FDA Device
- Class II
- terminated
- Published 2012-12-19
On 2012-12-19 the FDA classified a Class II recall of 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)… by Roche Molecular Systems, citing roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0487-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-16 |
| Published | 2012-12-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Roche Molecular Systems |
| Distribution | US |
Product
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.
Reason
Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Identifiers
| code_info | Device-associated diagnostic software |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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All Roche Molecular Systems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0487-2013%22
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