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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device instrument, coagulation, automated
Regulation Description Coagulation instrument.
Product CodeGKP
Regulation Number 864.5400
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 9
FISHER
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 8
INTERNATIONAL TECHNIDYNE CORP.
  SUBSTANTIALLY EQUIVALENT 1
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
No Known Device Problem 8
Low test results 5
Incorrect or inadequate result 4
High test results 3
Device operates differently than expected 3
Temperature issue 3
Data Issue 3
Patient Data Issue 3
Fail-safe mechanism issue 2
Fluid leak 2
Use of Device Issue 1
Improper device output 1
Device displays error message 1
Device markings issue 1
No Information 1
Total Device Problems 41

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 3 0 0 1 0 1 1 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Diagnostica Stago, Inc. II Oct-11-2007
2 Diagnostica Stago, Inc. II May-16-2007
3 Instrumentation Laboratory Co. II Jul-16-2014
4 Instrumentation Laboratory Co. II Sep-18-2013
5 Instrumentation Laboratory Co. II Sep-14-2012
6 Instrumentation Laboratory Co. II Oct-25-2010
7 Instrumentation Laboratory Co. II Aug-07-2007

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