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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cresolphthalein complexone, calcium
Regulation Description Calcium test system.
Product CodeCIC
Regulation Number 862.1145
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 3
ARKRAY USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 3
EMD
  SUBSTANTIALLY EQUIVALENT 1
HITACHI MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
KULZER
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1
TRACE SCIENTIFIC LTD.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
High test results 59
Low test results 50
Incorrect or inadequate test results 16
Device ingredient or reagent issue 8
Mechanical issue 1
Precipitate in device or device ingredient 1
Valve(s), failure of 1
Total Device Problems 136

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

Recalls
Manufacturer Recall Class Date Posted
1 Horiba Instruments, Inc dba Horiba Medical III Sep-26-2013
2 Pointe Scientific, Inc. II Mar-10-2010
3 Roche Diagnostics Operations, Inc. II Mar-25-2011
4 Siemens Healthcare Diagnostics, Inc. II Oct-04-2016

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