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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 9
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 9
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 19
Trek Diagnostic Systems
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
False negative result 9
Break 4
False positive result 3
Incorrect or inadequate result 2
Improper or incorrect procedure or method 2
Device markings issue 2
Device handling issue 2
No Information 1
Patient Data Issue 1
Loss of Data 1
Use of Device Issue 1
Total Device Problems 28

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 4 1 0 0 3 2 2 2 1 1
Class III 0 0 0 1 0 1 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. II Jan-30-2014
2 Becton Dickinson & Co. II Oct-19-2013
3 Becton Dickinson & Co. II Mar-27-2012
4 Becton Dickinson & Co. II Jul-28-2011
5 Becton Dickinson & Co. II Jun-23-2011
6 Becton Dickinson & Co. III Mar-08-2010
7 Biomerieux Inc II Nov-16-2012
8 Remel Inc II Jun-25-2015
9 Remel Inc II Jul-15-2014
10 Trek Diagnostic Systems III Sep-06-2012
11 bioMerieux, Inc. II Feb-04-2016
12 bioMerieux, Inc. II Jan-25-2013
13 bioMerieux, Inc. II May-24-2011
14 bioMerieux, Inc. II Jan-04-2008
15 bioMerieux, Inc. II May-18-2007
16 bioMerieux, Inc. II May-03-2007
17 bioMerieux, Inc. II Mar-22-2007
18 bioMerieux, Inc. II Mar-22-2007

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