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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 116
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 70
DADE
  SUBSTANTIALLY EQUIVALENT 2
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 37

Device Problems
Incorrect or inadequate result 70
Incorrect or inadequate test results 4
Device operates differently than expected 4
No Known Device Problem 3
Low test results 3
False positive result 3
False negative result 2
False device output 2
Therapeutic or diagnostic output failure 2
Product quality issue 2
Patient Data Issue 1
Device packaging compromised 1
Failure to obtain samples 1
Battery issue 1
Contamination of device ingredient or reagent 1
Fluid leak 1
Smoking 1
Device inoperable 1
Improper or incorrect procedure or method 1
Total Device Problems 104

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 1 1 0 1 1 0 0
Class II 0 0 1 2 1 2 0 0 0 1
Class III 0 0 0 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 II May-03-2016
6 Biomerieux Inc I Apr-27-2011
7 Biomerieux Inc I Nov-11-2010
8 Biomerieux Inc II Aug-27-2010
9 Siemens Healthcare Diagnostics, Inc. I Nov-07-2014
10 Siemens Healthcare Diagnostics, Inc. I Sep-11-2013
11 Siemens Microscan II Feb-04-2009

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