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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device analyzer, chemistry, micro, for clinical use
Regulation Description Micro chemistry analyzer for clinical use.
Product CodeJJF
Regulation Number 862.2170
Device Class 1


Premarket Reviews
ManufacturerDecision
ARKRAY USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
DIASORIN
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 2
NOVA
  SUBSTANTIALLY EQUIVALENT 2
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
High test results 6
Low test results 2
Output, low 2
Malfunction 2
Precision 1
Incorrect or inadequate result 1
Smoking 1
False negative result 1
Melted 1
Device emits odor 1
Total Device Problems 18

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

Recalls
Manufacturer Recall Class Date Posted
1 Roche Diagnostics Corp. II Dec-12-2007
2 Roche Molecular Systems, Inc. II Aug-15-2012
3 Roche Molecular Systems, Inc. II Aug-02-2007

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