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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
Spark 2
Smoking 2
Vibration 1
Device displays error message 1
Computer operating system issue 1
Device markings issue 1
Flare or flash 1
Burn of device or device component 1
Charred 1
Circuit Failure 1
Fire 1
Melted 1
Overheating of device or device component 1
Total Device Problems 15

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 1 0 0 2 2 2 1 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Molecular II Jan-09-2015
2 Abbott Molecular II Nov-25-2014
3 Abbott Molecular II Aug-08-2014
4 Abbott Molecular II Jan-03-2013
5 Abbott Molecular II Jan-11-2012
6 Roche Diagnostics Operations, Inc. II Dec-18-2013
7 Roche Molecular Systems, Inc. II Apr-27-2016
8 Roche Molecular Systems, Inc. II Dec-23-2012
9 Roche Molecular Systems, Inc. II Aug-27-2009

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