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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device acid, lactic, enzymatic method
Regulation Description Lactic acid test system.
Product CodeKHP
Regulation Number 862.1450
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 2
I-STAT
  SUBSTANTIALLY EQUIVALENT 2
NOVA
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Device displays error message 3
Display misread 2
Low test results 2
False negative result 1
Computer operating system issue 1
Communication or transmission issue 1
High Readings 1
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 3 1 3 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Jan-28-2015
2 Beckman Coulter Inc. II Jun-27-2013
3 Beckman Coulter Inc. II May-24-2013
4 Horiba Instruments Inc II Feb-02-2016
5 Radiometer America Inc II Sep-30-2013
6 Siemens Healthcare Diagnostics Inc II Sep-24-2015
7 Siemens Healthcare Diagnostics Inc II Aug-28-2015
8 Siemens Healthcare Diagnostics Inc II Jul-18-2014

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