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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device slide stainer, automated
Regulation Description Automated slide stainer.
Product CodeKPA
Regulation Number 864.3800
Device Class 1


Premarket Reviews
ManufacturerDecision
WESCOR, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
No Known Device Problem 9
Data Issue 9
No Information 5
No code available 3
Incorrect or inadequate result 3
Failure to deliver 2
Inaccurate delivery 2
Inaccurate dispensing 2
Unintended movement 1
Malposition of device 1
False negative result 1
False positive result 1
Fluid leak 1
Use of Device Issue 1
Improper or incorrect procedure or method 1
Component missing 1
Total Device Problems 43

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

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Molecular II Aug-31-2010
2 Beckman Coulter Inc II Feb-25-2010
3 Beckman Coulter Inc. II Aug-20-2012
4 Dako Denmark A/S II Dec-19-2012
5 Dako North America Inc. II Apr-29-2015
6 Dako North America Inc. II Mar-16-2015
7 Dako North America Inc. II Sep-26-2014
8 Hardy Diagnostics II Jul-08-2016
9 Ventana Medical Systems Inc II Aug-28-2013
10 Ventana Medical Systems Inc II Aug-06-2013
11 Ventana Medical Systems Inc II Jan-24-2008

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