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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device system, test, immunological, antigen, tumor
Regulation Description Tumor-associated antigen immunological test system.
Product CodeMOI
Regulation Number 866.6010
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
BAYER
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 2
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Mechanical issue 15
High test results 8
No Known Device Problem 8
Incorrect or inadequate test results 3
Failure to calibrate 2
Computer software issue 1
False negative result 1
False reading from device non-compliance 1
Low test results 1
Calibration issue 1
Device ingredient or reagent issue 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 0 2 0 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 Siemens Healthcare Diagnostics, Inc II Dec-11-2012
3 Siemens Healthcare Diagnostics, Inc II Oct-28-2012

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