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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cyclosporine
Regulation Description Cyclosporine test system.
Product CodeMKW
Regulation Number 862.1235
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 4
SIEMENS
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
High test results 2
Low test results 2
No Known Device Problem 1
Incorrect or inadequate result 1
Total Device Problems 6

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

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Nov-04-2011
2 Roche Diagnostics Operations, Inc. III Apr-15-2011
3 Siemens Healthcare Diagnostics, Inc. II May-21-2014
4 Siemens Healthcare Diagnostics, Inc. II Jan-23-2014

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