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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device flow cytometric reagents and accessories.
Regulation Description Automated differential cell counter.
Definition To identify and classify cells or other particles in suspension by their inherent physical properties or associated fluorescent molecules in order to provide information about the distribution or number cells in suspension or their level of protein expression. These characteristics may aid in the diagnosis of conditions such as immunodeficiency and cancer.
Product CodeOYE
Regulation Number 864.5220
Device Class 2


Premarket Reviews
ManufacturerDecision
BD
  SUBSTANTIALLY EQUIVALENT 2
  1.  BK150307  Automated differential Cell Counter
  2.  K141468  BD FACSCanto II flow cytometer (4-2-2 and 5-3 conf ...
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Fluid leak 2
Leak 1
Mechanical issue 1
Pressure issue 1
Burn of device or device component 1
Charred 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 0 0 0 0 1 1 2
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 BD Biosciences, Systems & Reagents II Jun-26-2015
2 BD Biosciences, Systems & Reagents II Jul-02-2014
3 Beckman Coulter Inc. II Nov-21-2016
4 Beckman Coulter Inc. II Sep-28-2016

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