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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device test,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
Product CodeMTG
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
7 7 3 9 25 17 12 13 7 0

Device Problems
High test results 7
Incorrect or inadequate test results 3
Incorrect or inadequate result 1
Total Device Problems 11

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 0 0 0 0 0
Class III 0 0 0 0 0 1 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc II Sep-16-2009
2 Beckman Coulter Inc. III May-22-2012

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