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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device processor, tissue, automated
Regulation Description Automated tissue processor.
Product CodeIEO
Regulation Number 864.3875
Device Class 1

Device Problems
Improper or incorrect procedure or method 103
No Known Device Problem 56
Use of Device Issue 14
No code available 12
Device operates differently than expected 11
Device displays error message 5
Leak 2
Mechanical issue 2
Device handling issue 2
No Information 2
Therapeutic or diagnostic output failure 1
Product quality issue 1
Unknown (for use when the device problem is not known) 1
Human-Device Interface Issue 1
Maintenance does not comply to manufacturers recommendations 1
Total Device Problems 214

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

Recalls
Manufacturer Recall Class Date Posted
1 Leica Microsystems, Inc. II Sep-22-2015
2 Leica Microsystems, Inc. III Sep-17-2015
3 Leica Microsystems, Inc. II Jul-29-2013
4 Leica Microsystems, Inc. II Apr-27-2012
5 Leica Microsystems, Inc. II Jun-20-2011
6 Leica Microsystems, Inc. II May-07-2010
7 Thermo Fisher Scientific II Apr-12-2010

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