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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device reagents,specific,analyte
Regulation Description Analyte specific reagents.
Product CodeMVU
Regulation Number 864.4020
Device Class 1

Device Problems
False positive result 1
Incorrect or inadequate result 1
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 0 1 0 0 0 2 4 0
Class III 1 0 0 0 0 1 0 1 0 2

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Molecular III Apr-23-2014
2 Abbott Molecular III Mar-13-2007
3 BD Biosciences, Systems & Reagents II Apr-02-2015
4 BD Biosciences, Systems & Reagents II Jan-20-2015
5 BD Biosciences, Systems & Reagents II May-01-2014
6 BD Biosciences, Systems & Reagents II Dec-02-2010
7 Becton, Dickinson and Company, BD Biosciences III Feb-23-2016
8 Becton, Dickinson and Company, BD Biosciences III Jan-11-2016
9 Becton, Dickinson and Company, BD Biosciences II Nov-24-2015
10 Becton, Dickinson and Company, BD Biosciences II Aug-24-2015
11 Lab Vision Corporation II Jan-16-2014
12 Phadia US Inc III Feb-17-2012

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