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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device clinical sample concentrator
Regulation Description Clinical sample concentrator.
Product CodeJJH
Regulation Number 862.2310
Device Class 1


Premarket Reviews
ManufacturerDecision
MILLIPORE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Burn of device or device component 1
Fire 1
Melted 1
Smoking 1
Vibration 1
Spark 1
Total Device Problems 6

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 1 0 0 2 1
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Molecular II Jan-03-2013
2 Abbott Molecular II Jan-11-2012
3 Roche Molecular Systems, Inc. II Dec-23-2012
4 Roche Molecular Systems, Inc. II Aug-27-2009

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