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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, test, amino acids, free carnitines and acylcarnitines tandem mass spectrometry
Regulation Description Newborn screening test system for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry.
Definition Amino acids, free carnitines and acylcarnitines test system is intended for the measurement and evaluation of amino acid, free carnitine and acylcarnitine concentrations from newborn whole blood filter paper samples. The quantitative analysis of the amino acids, free carnitines and acylcarnitines and their relationship with each other is intended to provide analyte concentration profiles that should aid in identifying elevated levels of these metabolites for screening newborns for one or more of several metabolic disorders.
Product CodeNQL
Regulation Number 862.1055
Device Class 2

Device Problems
False negative result 1
No Known Device Problem 1
Total Device Problems 2

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

Recalls
Manufacturer Recall Class Date Posted
1 Perkinelmer II Jan-16-2013

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