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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device colorimetry, acetaminophen
Regulation Description Acetaminophen test system.
Product CodeLDP
Regulation Number 862.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 3
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
Diagnostic Chemicals Ltd.
  SUBSTANTIALLY EQUIVALENT 3
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
High test results 9
Malfunction 7
Low test results 3
Total Device Problems 19

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 1 1 0 0 1 2 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories Inc. II Sep-18-2007
2 Alere San Diego, Inc. II Sep-26-2012
3 Beckman Coulter Inc II Sep-25-2008
4 Roche Diagnostics Operations, Inc. II Mar-16-2011
5 Sekisui Diagnostics Llc II Jun-27-2012

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