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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device enzyme immunoassay, phenobarbital
Regulation Description Phenobarbital test system.
Product CodeDLZ
Regulation Number 862.3660
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 3
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 2
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Malfunction 1
Total Device Problems 1

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 1 0 0 0 0 3 5 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories Inc. II Jan-09-2007
2 Abbott Laboratories, Inc II Apr-15-2013
3 Beckman Coulter Inc. II Mar-06-2012
4 Ortho-Clinical Diagnostics II Nov-15-2013
5 Ortho-Clinical Diagnostics II Apr-19-2013
6 Ortho-Clinical Diagnostics II Feb-28-2012
7 Siemens Healthcare Diagnostics, Inc. II Nov-07-2013
8 Siemens Healthcare Diagnostics, Inc. II Jan-10-2013
9 Siemens Healthcare Diagnostics, Inc. II Oct-10-2012

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