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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device culture media, antimicrobial susceptibility test, excluding mueller hinton agar
Regulation Description Culture medium for antimicrobial susceptibility tests.
Product CodeJSO
Regulation Number 866.1700
Device Class 2


Premarket Reviews
ManufacturerDecision
BD
  SUBSTANTIALLY EQUIVALENT 5
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 3
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 5
FISHER SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Incorrect or inadequate result 18
False positive result 14
Incorrect or inadequate test results 2
No Known Device Problem 1
Unable to obtain readings 1
Break 1
Total Device Problems 37

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 2 0 0 2 2 0 0 0 3 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 DRG International Inc II Mar-11-2010
2 Gibson Laboratories Inc II Feb-24-2010
3 Hardy Diagnostics II Aug-26-2015
4 Hardy Diagnostics II Jul-29-2015
5 Hardy Diagnostics II Jul-22-2015
6 Pml Microbiologicals Inc. II Oct-10-2007
7 Pml Microbiologicals Inc. II Oct-10-2007
8 Remel Inc II Aug-03-2011
9 Remel Inc II Jun-28-2011

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