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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrode, ion specific, sodium
Regulation Description Sodium test system.
Product CodeJGS
Regulation Number 862.1665
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
BAYER
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 2
BIONOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 2
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 2
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 2
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 3
I-STAT
  SUBSTANTIALLY EQUIVALENT 4
NOVA
  SUBSTANTIALLY EQUIVALENT 18
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 2
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 6

Device Problems
Low test results 170
High test results 43
Incorrect or inadequate test results 28
Incorrect or inadequate result 6
Output, low 5
Imprecision 2
Mechanical issue 1
Calibration issue 1
Device maintenance issue 1
Device clogged 1
Precision 1
Incorrect measurement 1
Total Device Problems 260

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

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Point Of Care Inc. II Apr-18-2011
2 Abbott Point of Care Inc. II Dec-11-2007
3 Beckman Coulter Inc II Sep-21-2008
4 Beckman Coulter Inc. II Apr-26-2011
5 Horiba Instruments, Inc dba Horiba Medical II Apr-18-2013
6 Opti Medical Systems Inc II Nov-09-2007
7 Ortho-Clinical Diagnostics II Feb-25-2014
8 Radiometer America Inc II Jan-23-2014
9 Siemens Healthcare Diagnostics II Nov-18-2013
10 Siemens Healthcare Diagnostics, Inc. II Oct-30-2015
11 Siemens Healthcare Diagnostics, Inc. II Apr-07-2015

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