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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ldl & vldl precipitation, cholesterol via esterase-oxidase, hdl
Regulation Description Lipoprotein test system.
Product CodeLBS
Regulation Number 862.1475
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 4
BAYER
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 3
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
CHOLESTECH CORP.
  SUBSTANTIALLY EQUIVALENT 2
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 1
Diagnostic Chemicals Ltd.
  SUBSTANTIALLY EQUIVALENT 1
GENZYME CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
KULZER
  SUBSTANTIALLY EQUIVALENT 2
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 2
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 2
POLYMEDCO, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Low test results 8
High test results 5
Mechanical issue 3
Incorrect or inadequate test results 1
No Known Device Problem 1
Total Device Problems 18

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 1 0 0 0 1 1 0 1 1 1
Class III 0 0 0 0 0 0 0 0 0 1 0

Recalls
Manufacturer Recall Class Date Posted
1 Alere San Diego, Inc. III Sep-10-2016
2 Beckman Coulter Inc. II May-12-2017
3 Ortho-Clinical Diagnostics II Nov-15-2013
4 Ortho-Clinical Diagnostics II Mar-26-2012
5 Roche Diagnostics Corp. II Oct-09-2008
6 Roche Diagnostics Operations, Inc. II Jun-27-2015
7 Siemens Healthcare Diagnostics, Inc. II May-11-2016

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