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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tubes, vacuum sample, with anticoagulant
Regulation Description Blood specimen collection device.
Product CodeGIM
Regulation Number 862.1675
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
BD
  SUBSTANTIALLY EQUIVALENT 2
INTERNATIONAL TECHNIDYNE CORP.
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 3
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
THE UNIVERSITY OF CHICAGO
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Crack 1
Shielding failure 1
Total Device Problems 2

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 0 2 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Greiner Bio-One North America, Inc. II Aug-07-2012
2 bioMerieux, Inc. II Mar-30-2012

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