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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device centrifuge, hematocrit
Regulation Description Hematocrit measuring device.
Product CodeGKG
Regulation Number 864.6400
Device Class 2


Premarket Reviews
ManufacturerDecision
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
SEPARATION TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 2
STATSPIN, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device inoperable 12
Burn of device or device component 5
Melted 3
Device operates differently than expected 3
Smoking 2
Detachment of device component 2
Component falling 1
Leak 1
Loose or intermittent connection 1
Mechanical issue 1
Device emits odor 1
Charred 1
Loss of threshold 1
Physical resistance 1
Noise, Audible 1
Break 1
Total Device Problems 37

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 1 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Hettich Instruments Management I I Jan-21-2010

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