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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device microtome, cryostat
Regulation Description Tissue processing equipment.
Product CodeIDP
Regulation Number 864.3010
Device Class 1

Device Problems
Use of Device Issue 3
No Known Device Problem 3
Human-Device Interface Issue 2
Improper or incorrect procedure or method 1
Tube(s), buckling of 1
Total Device Problems 10

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

Recalls
Manufacturer Recall Class Date Posted
1 Thermo Fisher Scientific II Mar-21-2011

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