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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device enzyme immunoassay, methadone
Regulation Description Methadone test system.
Product CodeDJR
Regulation Number 862.3620
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 3
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
FISHER SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
ORASURE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
PHAMATECH
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Incorrect or inadequate result 2
Incorrect or inadequate test results 1
Use of Incorrect Control Settings 1
False positive result 1
Total Device Problems 5

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

Recalls
Manufacturer Recall Class Date Posted
1 Alere San Diego dba Biosite Innovacon Hemosense Inc II Apr-20-2012
2 Alere San Diego, Inc. II Mar-17-2014
3 Alere San Diego, Inc. II Oct-10-2012
4 Alere San Diego, Inc. II Jul-19-2012
5 Sun Biomedical Laboratories, Inc. II Sep-17-2008

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