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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 270
False negative result 169
Incorrect or inadequate result 110
Leak 27
Device inoperable 26
Fluid leak 20
Low test results 19
Output issue 18
Charred 14
Device emits odor 9
Burn of device or device component 7
False positive result 7
Incorrect or inadequate test results 7
Issue with displayed error message 7
Optical distortion 6
High test results 5
Improper device output 4
Device displays error message 3
Smoking 3
Pumping issue 3
Failure to prime 2
No flow 2
Melted 2
Crack 2
Device-device incompatibility 2
Electrical shorting 1
Mechanical jam 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
Communication or transmission issue 1
Component or accessory incompatibility 1
Obstruction within device 1
Failure to calibrate 1
Application interface becomes non-functional or program exits abnormally 1
Altitude variations 1
Device clogged 1
Loose or intermittent connection 1
Loss of power 1
Increase in pressure 1
Total Device Problems 762

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

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

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