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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device discs, strips and reagents, microorganism differentiation
Regulation Description Microorganism differentiation and identification device.
Product CodeJTO
Regulation Number 866.2660
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
BD
  SUBSTANTIALLY EQUIVALENT 3
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
PFIZER
  SUBSTANTIALLY EQUIVALENT 1
SERIM RESEARCH CORP.
  SUBSTANTIALLY EQUIVALENT 1
WARNER-LAMBERT CO.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect or inadequate result 65
No code available 4
Incorrect or inadequate test results 3
Low readings 1
Use of Device Issue 1
Break 1
False negative result 1
Unable to obtain readings 1
Total Device Problems 77

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

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. II May-29-2013
2 Becton Dickinson & Co. III Mar-04-2010
3 Remel Inc II Dec-18-2013

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