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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, test, carcinoembryonic antigen
Regulation Description Tumor-associated antigen immunological test system.
Product CodeDHX
Regulation Number 866.6010
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
BAYER
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 3
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
DPC
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 2
PACIFIC HEMOSTASIS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Low test results 19
High test results 12
False negative result 11
No Known Device Problem 10
Incorrect or inadequate result 7
Incorrect or inadequate test results 5
Low readings 4
Other (for use when an appropriate device code cannot be identified) 1
Nonstandard device or device component 1
No Information 1
Total Device Problems 71

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 1 0 0 0 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Nov-06-2015
2 BioCheck Inc II Mar-11-2011

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