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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device counter, cell, automated (particle counter)
Regulation Description Automated cell counter.
Product CodeGKL
Regulation Number 864.5200
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 7
BAYER
  SUBSTANTIALLY EQUIVALENT 3
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 4
KULZER
  SUBSTANTIALLY EQUIVALENT 1
NOVA
  SUBSTANTIALLY EQUIVALENT 1
SYSMEX
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
Unknown (for use when the device problem is not known) 7
High test results 4
Low test results 3
Other (for use when an appropriate device code cannot be identified) 2
Incorrect or inadequate test results 2
High impedance 1
Incorrect or inadequate result 1
Total Device Problems 20

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

Recalls
Manufacturer Recall Class Date Posted
1 BD Biosciences, Systems & Reagents II Jan-20-2015
2 Beckman Coulter Inc II Dec-22-2007
3 Beckman Coulter Inc. II Apr-12-2011
4 Becton, Dickinson and Company, BD Biosciences III Apr-14-2016
5 Siemens Healthcare Diagnostics II Aug-28-2013

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