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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device fluorometer, for clinical use
Regulation Description Fluorometer for clinical use.
Product CodeKHO
Regulation Number 862.2560
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 3
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 1
RADIOMETER
  SUBSTANTIALLY EQUIVALENT 1
TOSOH CORP.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
False reading from device non-compliance 46
Incorrect or inadequate result 46
Maintenance does not comply to manufacturers recommendations 46
Output issue 46
High test results 11
No Known Device Problem 8
Mechanical issue 3
Inadequate training 2
Failure to calibrate 1
Low test results 1
Overheating of device or device component 1
Fluid leak 1
Imprecision 1
Temperature issue 1
False negative result 1
Total Device Problems 215

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 0 0 2 1 0 1 0 1
Class III 0 0 0 0 0 0 0 0 1 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Ortho-Clinical Diagnostics II Jan-27-2012
2 PerkinElmer Life and Analytical Sciences, Wallac, OY II Jan-27-2017
3 PerkinElmer Life and Analytical Sciences, Wallac, OY II Feb-28-2012
4 Tecan US, Inc. II Jul-02-2015
5 Tecan US, Inc. III Jan-15-2015
6 Tosoh Smd Inc II Jul-30-2013

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