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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 2
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 3
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 1
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 2
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
KULZER
  SUBSTANTIALLY EQUIVALENT 1
NOVA
  SUBSTANTIALLY EQUIVALENT 4
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 2
OSMETECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
POLYMEDCO, INC.
  SUBSTANTIALLY EQUIVALENT 1
RADIOMETER
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Low test results 262
High test results 142
Incorrect or inadequate test results 88
Leak 21
Fluid leak 19
Incorrect or inadequate result 13
Malfunction 6
False positive result 5
No Known Device Problem 4
Output, low 4
Parameter calculation error due to software problem 2
Contamination during use 2
Design/structure problem 2
Defective item 2
Tubing, incorrect placement of 2
Device Issue 2
Sensor problems 1
Smoking 1
Traditional use 1
Unable to confirm conditions of use 1
Device ingredient or reagent issue 1
High Readings 1
False negative result 1
False device output 1
Imprecision 1
Break 1
Device clogged 1
Computer software issue 1
Precision 1
Probe failure 1
Loose or intermittent connection 1
Incorrect measurement 1
Mislabeled 1
Output, high 1
Total Device Problems 594

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 1 0 0 0 0 0
Class II 0 0 1 1 4 1 1 0 2 0
Class III 0 0 0 0 0 0 1 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Jun-27-2015
2 Beckman Coulter Inc. II Aug-10-2013
3 Beckman Coulter Inc. II Nov-19-2012
4 Beckman Coulter Inc. II Apr-26-2011
5 Beckman Coulter Inc. II Mar-09-2011
6 Epocal II Feb-06-2009
7 Instrumentation Laboratory Co. I Jul-21-2011
8 Ortho-Clinical Diagnostics III Jun-27-2013
9 Radiometer America Inc II Apr-28-2011
10 Radiometer America Inc II Feb-02-2011
11 Siemens Healthcare Diagnostics, Inc. II Apr-07-2015
12 Siemens Healthcare Diagnostics, Inc. II Oct-25-2010

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