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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device enzyme linked immunoabsorbent assay, toxoplasma gondii
Regulation Description Toxoplasma gondii serological reagents.
Product CodeLGD
Regulation Number 866.3780
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 10
BAYER
  SUBSTANTIALLY EQUIVALENT 3
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 5
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 5
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 3
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 3
DIASORIN
  SUBSTANTIALLY EQUIVALENT 2
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 2
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
False positive result 149
Incorrect or inadequate result 28
False negative result 25
High test results 24
Incorrect or inadequate test results 18
No Known Device Problem 10
Low test results 5
Mechanical issue 3
No Information 3
Incorrect measurement 1
Low readings 1
Total Device Problems 267

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

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Jul-11-2007
2 BioCheck Inc II Mar-11-2011
3 Calbiotech Inc II Mar-05-2010

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