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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device medical computers and software
Product CodeLNX
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 1 0
Class II 0 0 0 10 5 0 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Baxa Corporation I May-25-2012
2 SCC Soft Computer II Dec-02-2011
3 SCC Soft Computer II Dec-02-2011
4 SCC Soft Computer II Nov-23-2011
5 SCC Soft Computer II Nov-23-2011
6 SCC Soft Computer II Jun-30-2011
7 SCC Soft Computer II Nov-15-2010
8 SCC Soft Computer II Oct-20-2010
9 SCC Soft Computer II Oct-20-2010
10 SCC Soft Computer II Oct-20-2010
11 SCC Soft Computer II Oct-19-2010
12 SCC Soft Computer II Oct-19-2010
13 SCC Soft Computer II Oct-19-2010
14 SCC Soft Computer II Oct-18-2010
15 SCC Soft Computer II Oct-15-2010
16 SCC Soft Computer II Oct-15-2010

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