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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device automated urinalysis system
Regulation Description Automated urinalysis system.
Product CodeKQO
Regulation Number 862.2900
Device Class 1


Premarket Reviews
ManufacturerDecision
ARKRAY USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
BAYER
  SUBSTANTIALLY EQUIVALENT 2
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 6
KULZER
  SUBSTANTIALLY EQUIVALENT 2
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device operates differently than expected 348
False negative result 175
Incorrect or inadequate result 128
Leak 47
Fluid leak 27
Device inoperable 26
Low test results 22
Output issue 19
Charred 14
Incorrect or inadequate test results 13
Burn of device or device component 10
Device emits odor 9
False positive result 7
Issue with displayed error message 7
Optical distortion 6
High test results 5
Improper device output 4
Melted 4
Smoking 3
Device displays error message 3
Protective measure issue 3
Pumping issue 3
Failure to prime 2
No flow 2
Device-device incompatibility 2
Communication or transmission issue 2
Crack 2
Application interface becomes non-functional or program exits abnormally 1
Altitude variations 1
Device clogged 1
Loss of power 1
Increase in pressure 1
Loose or intermittent connection 1
Component or accessory incompatibility 1
Electrical shorting 1
Improper flow or infusion 1
Inadequate lighting 1
Incorrect device or component shipped 1
Installation-related problem 1
Spark 1
Application program version or upgrade problem 1
Obstruction within device 1
Failure to calibrate 1
Mechanical jam 1
Total Device Problems 910

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 1 0 1 1 0 1 1 1
Class III 0 0 0 0 0 0 0 1 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Mar-01-2017
2 Beckman Coulter Inc. II Mar-08-2016
3 HemoCue AB II Oct-25-2013
4 Iris Diagnostics II Aug-21-2015
5 Siemens Healthcare Diagnostics Inc III May-04-2014
6 Teco Diagnostics II Jan-11-2012
7 Teco Diagnostics II Dec-09-2010

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