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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system,test,thyroglobulin
Regulation Description Tumor-associated antigen immunological test system.
Product CodeMSW
Regulation Number 866.6010
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 2
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
Nichols Institute Diagnostics
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Material rigid or stiff 4
Connection issue 2
No Known Device Problem 1
Positioning Issue 1
Pressure issue 1
High test results 1
Break 1
Total Device Problems 11

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 1 0 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Sep-03-2015
2 Beckman Coulter Inc. II May-19-2011

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