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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device susceptibility test cards, antimicrobial
Regulation Description Antimicrobial susceptibility test powder.
Product CodeLTW
Regulation Number 866.1640
Device Class 2


Premarket Reviews
ManufacturerDecision
MICROTEK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect or inadequate result 3
False negative result 1
Total Device Problems 4

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

Recalls
Manufacturer Recall Class Date Posted
1 Biomerieux Inc I May-11-2016
2 Biomerieux Inc II May-12-2015
3 Biomerieux Inc III Apr-08-2015
4 Biomerieux Inc II Aug-06-2013
5 Biomerieux Inc II Mar-27-2013
6 Biomerieux Inc II Mar-25-2013
7 Biomerieux Inc II Jul-09-2011

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