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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:114106

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 recall number

Z-0487-2013

Evidence summary

Product code
NSX
Recall status
Terminated
Event initiated
July 16, 2012
Root cause
Software design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0487-2013