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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, microtiter diluting/dispensing
Regulation Description Microtiter diluting and dispensing device.
Product CodeJTC
Regulation Number 866.2500
Device Class 1


Premarket Reviews
ManufacturerDecision
HAMILTON
  SUBSTANTIALLY EQUIVALENT 3
MICROTEK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Device alarm system issue 11
Aspiration issue 9
Malfunction 2
Failure to obtain samples 2
Incorrect or inadequate test results 1
High test results 1
Device markings issue 1
Maintenance does not comply to manufacturers recommendations 1
Contamination during use 1
Display misread 1
Unintended ejection 1
Fluid leak 1
Device maintenance issue 1
Mechanical issue 1
Improper or incorrect procedure or method 1
Total Device Problems 35

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

Recalls
Manufacturer Recall Class Date Posted
1 Copan Italia III Aug-30-2013
2 Hamilton Co III Sep-09-2009
3 Hamilton Co II Apr-17-2009
4 Hamilton Co II Feb-08-2008
5 Hamilton Co II Apr-07-2007

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