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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device diluent, blood cell
Regulation Description Blood cell diluent.
Product CodeGIF
Regulation Number 864.8200
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
EMD
  SUBSTANTIALLY EQUIVALENT 1
SYSMEX
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device ingredient or reagent issue 7
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 4 0 0 0 0 0 0 1 2 0
Class III 1 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Apr-03-2007
2 Abbott Laboratories II Apr-03-2007
3 Abbott Laboratories II Mar-17-2007
4 Abbott Laboratories II Mar-16-2007
5 Abbott Laboratories III Mar-01-2007
6 Beckman Coulter Inc. II Aug-28-2015
7 Beckman Coulter Inc. II May-15-2015
8 Beckman Coulter Inc. II Sep-16-2014

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