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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bilirubin (total and unbound) in the neonate test system
Regulation Description Bilirubin (total and unbound) in the neonate test system.
Product CodeMQM
Regulation Number 862.1113
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
HILL-ROM, INC.
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
RADIOMETER
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect or inadequate test results 5
High test results 4
Low test results 2
Total Device Problems 11

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

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Healthcare Diagnostics Inc II Mar-06-2015

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