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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
No Known Device Problem 129
Improper or incorrect procedure or method 122
Use of Device Issue 29
No code available 22
Device operates differently than expected 12
Failure to cycle 7
Device displays error message 7
Device handling issue 3
Mechanical issue 3
No Information 2
Fluid leak 2
Leak 2
Unknown (for use when the device problem is not known) 1
Maintenance does not comply to manufacturers recommendations 1
Not Applicable 1
Therapeutic or diagnostic output failure 1
Human-Device Interface Issue 1
Product quality issue 1
Total Device Problems 346

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