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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device test, epithelial ovarian tumor-associated antigen (ca125)
Regulation Description Tumor-associated antigen immunological test system.
Product CodeLTK
Regulation Number 866.6010
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
BAYER
  SUBSTANTIALLY EQUIVALENT 3
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 2
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 2
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 2
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
High test results 17
Incorrect or inadequate test results 14
Defective item 4
Low test results 2
High Readings 1
False positive result 1
Incorrect or inadequate result 1
Device ingredient or reagent issue 1
No Known Device Problem 1
Total Device Problems 42

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

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Jul-11-2007
2 BioCheck Inc II Mar-11-2011
3 Ortho-Clinical Diagnostics II Dec-17-2013
4 Siemens Healthcare Diagnostics, Inc II Mar-02-2011

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