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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, blood culturing
Regulation Description Microbial growth monitor.
Product CodeMDB
Regulation Number 866.2560
Device Class 1


Premarket Reviews
ManufacturerDecision
BD
  SUBSTANTIALLY EQUIVALENT 3
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 4
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 6
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 3
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 18
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
Trek Diagnostic Systems
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 3
Device handling issue 2
False positive result 1
Use of Device Issue 1
Improper or incorrect procedure or method 1
No Information 1
Total Device Problems 9

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 4 1 0 0 3 2 1
Class III 0 0 0 1 0 1 0

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. II Mar-27-2012
2 Becton Dickinson & Co. II Jul-28-2011
3 Becton Dickinson & Co. II Jun-23-2011
4 Becton Dickinson & Co. III Mar-08-2010
5 Biomerieux Inc II Nov-16-2012
6 Trek Diagnostic Systems III Sep-06-2012
7 bioMerieux, Inc. II Jan-25-2013
8 bioMerieux, Inc. II May-24-2011
9 bioMerieux, Inc. II Jan-04-2008
10 bioMerieux, Inc. II May-18-2007
11 bioMerieux, Inc. II May-03-2007
12 bioMerieux, Inc. II Mar-22-2007
13 bioMerieux, Inc. II Mar-22-2007

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