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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, test, her-2/neu, ihc
Product CodeMVC
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
4 0 0 6 6 5 13 7 7 3

Device Problems
No Known Device Problem 4
No Information 1
False negative result 1
Incorrect or inadequate result 1
Total Device Problems 7

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

Recalls
Manufacturer Recall Class Date Posted
1 Biogenex Laboratories, Inc. II Jul-24-2014
2 Ventana Medical Systems Inc II Mar-16-2010

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