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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, test, vitamin d
Regulation Description Vitamin D test system.
Product CodeMRG
Regulation Number 862.1825
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 2
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 1
DIASORIN
  SUBSTANTIALLY EQUIVALENT 6
ESA, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
High test results 7
Incorrect or inadequate test results 3
Low test results 2
Total Device Problems 12

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 1 4 1 0 0
Class III 2 2 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Jan-23-2013
2 Diasorin Inc. III May-07-2008
3 Diasorin Inc. III Sep-20-2007
4 Diasorin Inc. III Apr-03-2007
5 IDS (Immunodiagnostic Systems Ltd.) II Jan-18-2013
6 Immunodiagnostics Systems Inc III Oct-24-2008
7 Qualigen Inc II Dec-19-2013
8 Siemens Healthcare Diagnostics, Inc II May-23-2014
9 Siemens Healthcare Diagnostics, Inc II Apr-15-2013
10 Siemens Healthcare Diagnostics, Inc II Mar-21-2012

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