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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device enzyme immunoassay, diphenylhydantoin
Regulation Description Diphenylhydantoin test system.
Product CodeDIP
Regulation Number 862.3350
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 4
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 2
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Low test results 10
Incorrect or inadequate test results 9
Other (for use when an appropriate device code cannot be identified) 8
Imprecision 2
Nonstandard device or device component 2
Total Device Problems 31

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 0 0 0 0 1 3 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories Inc. II Sep-16-2008
2 Ortho-Clinical Diagnostics II Oct-02-2014
3 Ortho-Clinical Diagnostics II Nov-15-2013
4 Siemens Healthcare Diagnostics, Inc II Feb-04-2014
5 Siemens Healthcare Diagnostics, Inc. II Oct-29-2014

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