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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device enzyme immunoassay, tracrolimus
Regulation Description Tacrolimus test system.
Product CodeMLM
Regulation Number 862.1678
Device Class 2


Premarket Reviews
ManufacturerDecision
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Incorrect or inadequate test results 4
Low test results 3
Mechanical issue 3
High test results 2
Nonstandard device or device component 1
Unable to obtain readings 1
Incorrect or inadequate result 1
Use of Device Issue 1
Improper or incorrect procedure or method 1
Total Device Problems 17

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 2 0 0 3 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Oct-15-2010
2 Diasorin Inc. II Apr-20-2015
3 Siemens Healthcare Diagnostics, Inc. II Dec-16-2013
4 Siemens Healthcare Diagnostics, Inc. II Aug-07-2013
5 Siemens Healthcare Diagnostics, Inc. II Mar-15-2013
6 Siemens Healthcare Diagnostics, Inc. II Sep-13-2010

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