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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device sirolimus test system
Regulation Description Sirolimus test system.
Definition Sirolimus test systems are intended for the quantitative measurement of sirolimus in whole blood as an aid in management of transplant patients taking this sirolimus.
Product CodeNRP
Regulation Number 862.3840
Device Class 2


Premarket Reviews
ManufacturerDecision
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect or inadequate test results 7
Nonstandard device or device component 5
Device displays error message 4
High test results 3
Low test results 2
Display misread 1
Device markings issue 1
Improper device output 1
Total Device Problems 24

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

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Aug-03-2010
2 Abbott Laboratories II Aug-03-2010
3 Abbott Laboratories MPG II Feb-15-2007
4 Siemens Healthcare Diagnostics, Inc. II May-10-2016

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