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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device processor, cervical cytology slide, automated
Definition It is a system that is used to collect and prepare cervical cytology specimens for Pap stain-based screening for cervical cancer. The specimens are collected and rinsed into a liquid preservative fluid from which they are then automatically filtered and deposited in a thin-layer on a glass microscope slide. They are stained and screened by a cytotechnologist and cytopathologist.
Product CodeMKQ
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
5 5 4 5 2 2 2 7 2 4

Device Problems
Device operates differently than expected 2
Total Device Problems 2

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 1 0 0 1 1 0 0 0
Class III 0 0 0 0 0 2 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Bd Diagnostic Systems Tripath II Mar-19-2009
2 Becton Dickinson & Co. II Aug-28-2013
3 Tripath Imaging, Inc. II Jul-26-2012
4 Tripath Imaging, Inc. III Jun-15-2012
5 Tripath Imaging, Inc. III May-21-2012

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