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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device culture media, selective and differential
Regulation Description Selective culture medium.
Product CodeJSI
Regulation Number 866.2360
Device Class 1


Premarket Reviews
ManufacturerDecision
BD
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect or inadequate result 1
Incorrect or inadequate test results 1
Total Device Problems 2

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 1 0 0 0 0 0 2 0 2 2
Class III 0 0 0 1 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. II Apr-22-2016
2 Becton Dickinson & Co. II Jan-14-2015
3 Becton Dickinson & Co. II Jul-24-2013
4 Becton Dickinson & Co. II May-16-2013
5 Becton Dickinson & Co. III Jun-11-2010
6 Hardy Diagnostics II Apr-14-2015
7 Northeast Laboratory Services, Inc. II Apr-01-2016
8 Remel, Inc. II Mar-14-2007

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