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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device enzyme linked immunoabsorption assay, treponema pallidum
Regulation Description Treponema pallidum treponemal test reagents.
Product CodeLIP
Regulation Number 866.3830
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
DIASORIN
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
False negative result 2
False positive result 1
Total Device Problems 3

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

Recalls
Manufacturer Recall Class Date Posted
1 Bio-Rad Laboratories II Jun-26-2015
2 Bio-Rad Laboratories II Jun-11-2008
3 Bio-Rad Labroatories Inc. III Nov-09-2007
4 Clark Laboratories, Inc. (dba,Trinity Biotech USA) III Dec-16-2014
5 Clark Laboratories, Inc. (dba,Trinity Biotech USA) II Dec-26-2013
6 Siemens Healthcare Diagnostics, Inc II Aug-20-2012

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