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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device centrifuges (micro, ultra, refrigerated) for clinical use
Regulation Description General purpose laboratory equipment labeled or promoted for a specific medical use.
Product CodeJQC
Regulation Number 862.2050
Device Class 1


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 2
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 2
COBE INC.
  SUBSTANTIALLY EQUIVALENT 2
HARVEST
  SUBSTANTIALLY EQUIVALENT 2
IMPLANT INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
PALL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
THERMOGENESIS CORP.
  1

Device Problems
Break 95
Burn of device or device component 87
Device inoperable 84
Device operates differently than expected 76
Detachment of device component 45
Charred 40
Material fragmentation 27
Melted 14
Smoking 13
Mechanical issue 5
Misconnection 4
Device emits odor 4
Circuit Failure 4
Failure to service 3
Leak 2
Fire 2
Difficult to open or close 2
Electrical shorting 1
Electronic property issue 1
Manufacturing or shipping issue associated with device 1
Material integrity issue 1
Defective component 1
Device contamination with blood or blood product 1
Low test results 1
Fumes or vapors 1
Device displays error message 1
Device stops intermittently 1
Fracture 1
Inappropriate shock 1
Component falling 1
Intermittent continuity 1
Crack 1
Total Device Problems 522

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

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Jul-23-2016
2 Becton Dickinson & Co. III Mar-11-2010
3 Biomet, Inc. III Apr-17-2009
4 Global Focus Marketing & Develop I Jul-27-2011
5 Iris Diagnostics II Dec-23-2014
6 StatSpin, Inc., dba Iris Sample Processing II May-10-2011
7 StatSpin, Inc., dba Iris Sample Processing I Mar-04-2010

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