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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, potassium
Regulation Description Potassium test system.
Product CodeCEM
Regulation Number 862.1600
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 6
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 2
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 3
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 1
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 2
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
KULZER
  SUBSTANTIALLY EQUIVALENT 1
NOVA
  SUBSTANTIALLY EQUIVALENT 4
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
OSMETECH, INC.
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
POLYMEDCO, INC.
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
RADIOMETER
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Low test results 261
High test results 141
Incorrect or inadequate test results 82
Leak 21
Fluid leak 19
Incorrect or inadequate result 13
Malfunction 6
False positive result 5
Output, low 4
Parameter calculation error due to software problem 2
Contamination during use 2
Design/structure problem 2
Tubing, incorrect placement of 2
Device Issue 2
Defective item 2
Device ingredient or reagent issue 1
No Known Device Problem 1
High Readings 1
False negative result 1
Break 1
Device clogged 1
Computer software issue 1
Loose or intermittent connection 1
Incorrect measurement 1
Mislabeled 1
Output, high 1
Precision 1
Probe failure 1
Sensor problems 1
Smoking 1
Imprecision 1
Total Device Problems 580

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 1 0 0
Class II 0 0 1 1 4 1 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Nov-19-2012
2 Beckman Coulter Inc. II Apr-26-2011
3 Beckman Coulter Inc. II Mar-09-2011
4 Epocal II Feb-06-2009
5 Instrumentation Laboratory Co. I Jul-21-2011
6 Radiometer America Inc II Apr-28-2011
7 Radiometer America Inc II Feb-02-2011
8 Siemens Healthcare Diagnostics, Inc. II Oct-25-2010

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