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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, rubeola igg
Regulation Description Rubeola (measles) virus serological reagents.
Definition The qualitative detection of measles specific IgG antibodies in serum or plasma.
Product CodeLJB
Regulation Number 866.3520
Device Class 1

Device Problems
Incorrect or inadequate result 4
False negative result 2
False positive result 2
Fluid leak 1
Device damaged prior to use 1
Total Device Problems 10

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

Recalls
Manufacturer Recall Class Date Posted
1 Calbiotech Inc II Mar-05-2010
2 Diamedix Corporation II Jan-07-2009

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