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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device kit, test,alpha-fetoprotein for testicular cancer
Regulation Description Tumor-associated antigen immunological test system.
Product CodeLOJ
Regulation Number 866.6010
Device Class 2


Premarket Reviews
ManufacturerDecision
BAYER
  SUBSTANTIALLY EQUIVALENT 2
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect or inadequate test results 7
Low test results 3
High test results 2
Incorrect or inadequate result 1
Total Device Problems 13

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

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Sep-18-2009
2 Abbott Laboratories II Jan-09-2008
3 BioCheck Inc II Mar-11-2011
4 ORTHO-CLINICAL DIAGNOSTICS III Jul-08-2016

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