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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, test, automated, antimicrobial susceptibility, short incubation
Regulation Description Fully automated short-term incubation cycle antimicrobial susceptibility system.
Product CodeLON
Regulation Number 866.1645
Device Class 2


Premarket Reviews
ManufacturerDecision
BD
  SUBSTANTIALLY EQUIVALENT 61
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 47
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 22
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 42
DADE
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 21
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 16

Device Problems
False device output 1
Fluid leak 1
Incorrect or inadequate result 1
Improper or incorrect procedure or method 1
Total Device Problems 4

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

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. II Dec-19-2012
2 Becton Dickinson & Co. II May-24-2012
3 Becton Dickinson & Co. II Mar-30-2011
4 Becton Dickinson & Co. II Nov-15-2010
5 Biomerieux Inc I Apr-27-2011
6 Biomerieux Inc I Nov-11-2010
7 Biomerieux Inc II Aug-27-2010
8 Siemens Microscan II Feb-04-2009

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