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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device equipment, laboratory, general purpose, labeled or promoted for a specific medical use
Regulation Description General purpose laboratory equipment labeled or promoted for a specific medical use.
Product CodeLXG
Regulation Number 862.2050
Device Class 1


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Mechanical issue 3
Break 3
False negative result 2
Device operates differently than expected 2
Electrical shorting 1
Incorrect or inadequate result 1
Use of Device Issue 1
Incorrect or inadequate test results 1
Application program issue 1
Total Device Problems 15

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

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc II Oct-16-2007
2 Beckman Coulter Inc. II May-19-2011
3 Biomerieux Inc II Oct-09-2012
4 Roche Diagnostics Corp. II May-18-2009
5 Roche Diagnostics Operations, Inc. II Aug-29-2011
6 Siemens Healthcare Diagnostics Inc. II Jun-29-2016
7 Siemens Medical Solutions Diagnostics III Jun-19-2014

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