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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device lipase hydrolysis/glycerol kinase enzyme, triglycerides
Regulation Description Triglyceride test system.
Product CodeCDT
Regulation Number 862.1705
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 3
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 6
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 2
Diagnostic Chemicals Ltd.
  SUBSTANTIALLY EQUIVALENT 2
DOW
  SUBSTANTIALLY EQUIVALENT 2
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 1
  1.  K812029  KODAK EKTACHEM CLIN. CHEM. SLIDES (TRIG)
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 2
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
TRACE SCIENTIFIC LTD.
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Device ingredient or reagent issue 10
Incorrect or inadequate result 2
Incorrect or inadequate test results 2
High test results 1
Low test results 1
Total Device Problems 16

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 1 0 0 0 1 2 3
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Jan-28-2015
2 Horiba Instruments Inc II Feb-02-2016
3 Ortho-Clinical Diagnostics II Dec-22-2014
4 Roche Diagnostics Operations, Inc. II Jun-27-2015
5 Siemens Healthcare Diagnostics, Inc. II May-14-2016
6 Siemens Healthcare Diagnostics, Inc. II May-11-2016
7 Siemens Healthcare Diagnostics, Inc. II Mar-24-2010

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