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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device enzyme immunoassay, digoxin
Regulation Description Digoxin test system.
Product CodeKXT
Regulation Number 862.3320
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 4
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
BAYER
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 2
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 4
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 3
KULZER
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device displays error message 230
Incorrect or inadequate test results 68
High test results 8
Low test results 5
Malfunction 4
Total Device Problems 315

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 3 0 0 0 0 0 1
Class III 0 1 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Diagnostic International, Ltd. III Nov-21-2008
2 Abbott Diagnostic International, Ltd. II Nov-03-2007
3 Abbott Diagnostic International, Ltd. II Aug-29-2007
4 Roche Diagnostics Corp. II Apr-13-2007
5 Siemens Healthcare Diagnostics, Inc. II Apr-18-2013

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