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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 11
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 10
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 19
Trek Diagnostic Systems
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
False positive result 264
Incorrect or inadequate result 262
Contamination during use 27
False negative result 15
Device operates differently than expected 15
Device markings issue 12
Incorrect or inadequate test results 11
Break 4
Device handling issue 2
Device inoperable 2
Use of Device Issue 2
Improper or incorrect procedure or method 2
Fluid leak 2
Fracture 2
No device output 2
Device contamination with blood or blood product 1
Date-related software issue 1
Loss of Data 1
Output issue 1
No Information 1
Patient Data Issue 1
Total Device Problems 630

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 4 1 0 0 3 2 2 2 1 1 0
Class III 0 0 0 1 0 1 0 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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