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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device analyzer, chemistry (sequential multiple, continuous flow) clinical use
Regulation Description Continuous flow sequential multiple chemistry analyzer for clinical use.
Product CodeJJC
Regulation Number 862.2150
Device Class 1


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
  1.  K760211  ANALYZER, GLUCOSE/UREA/CREATININE
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
NOVA
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
High test results 9
Low test results 8
Incorrect or inadequate test results 8
Malfunction 3
Inadequate training 2
Computer software issue 2
Device emits odor 2
Output, low 1
Incorrect or inadequate result 1
False negative result 1
Total Device Problems 37

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 0 0 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0


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